Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT04482530
Collaborator
Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes (Other), Unité de recherche CSGA, INRAE Dijon (Other)
15
1
5
9
1.7

Study Details

Study Description

Brief Summary

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

Condition or Disease Intervention/Treatment Phase
  • Other: fruit paste matrice
N/A

Detailed Description

This is an interventional randomized, single blinded, cross over and controlled study.

The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.

The secondary objective is:

-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)

  • Informed consent form

  • Clinical examination

  • Medical history

  • Anthropometric characteristics

  • Blood biochemical and hematological assessment

  • Compliance test with the original matrix will be carried out

Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods.

Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix.

After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below).

Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method.

Visit 7 will be the last visit of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Masking Description:
Same flavor will be used for all matrices. The different matrices will be offered to volunteers in in individual packaged portions.
Primary Purpose:
Health Services Research
Official Title:
Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept
Actual Study Start Date :
May 31, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Original recipe

Normal fruit paste

Other: fruit paste matrice
Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Experimental: maltodextrin recipe

fruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).

Other: fruit paste matrice
Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Experimental: fructose recipe

fruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose

Other: fruit paste matrice
Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Experimental: isomaltulose recipe

fruit pastes with some of the sugars will be replaced (25% min) by isomaltulose

Other: fruit paste matrice
Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Experimental: mixed recipe

fruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose

Other: fruit paste matrice
Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Outcome Measures

Primary Outcome Measures

  1. Area Under the Curve (AUC) of glycemia [Day 0]

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  2. Maximum Plasma Concentration (Cmax) of glycemia [Day 0]

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  3. Time of Maximum Plasma Concentration (Tmax) of glycemia [Day 0]

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  4. Area Under the Curve (AUC) of glycemia [Day 7]

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  5. Maximum Plasma Concentration (Cmax) of glycemia [Day 7]

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  6. Time of Maximum Plasma Concentration (Tmax) of glycemia [day 7]

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  7. Area Under the Curve (AUC) of glycemia [day 14]

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  8. Maximum Plasma Concentration (Cmax) of glycemia [day 14]

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  9. Time of Maximum Plasma Concentration (Tmax) of glycemia [day 14]

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  10. Area Under the Curve (AUC) of glycemia [day 21]

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  11. Maximum Plasma Concentration (Cmax) of glycemia [day 21]

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  12. Time of Maximum Plasma Concentration (Tmax) of glycemia [day 21]

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  13. Area Under the Curve (AUC) of glycemia [day 28]

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  14. Maximum Plasma Concentration (Cmax) of glycemia [day 28]

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  15. Time of Maximum Plasma Concentration (Tmax) of glycemia [day 28]

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

Secondary Outcome Measures

  1. Area Under the Curve (AUC) of fructose [Day 0]

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  2. Maximum Plasma Concentration (Cmax) of fructose [Day 0]

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  3. Time of Maximum Plasma Concentration (Tmax) of fructose [Day 0]

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  4. Area Under the Curve (AUC) of fructose [Day 7]

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  5. Maximum Plasma Concentration (Cmax) of fructose [Day 7]

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  6. Time of Maximum Plasma Concentration (Tmax) of fructose [Day 7]

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  7. Area Under the Curve (AUC) of fructose [Day 14]

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  8. Maximum Plasma Concentration (Cmax) of fructose [Day 14]

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  9. Time of Maximum Plasma Concentration (Tmax) of fructose [Day 14]

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  10. Area Under the Curve (AUC) of fructose [Day 21]

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  11. Maximum Plasma Concentration (Cmax) of fructose [Day 21]

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  12. Time of Maximum Plasma Concentration (Tmax) of fructose [Day 21]

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  13. Area Under the Curve (AUC) of fructose [Day 28]

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

  14. Maximum Plasma Concentration (Cmax) of fructose [Day 28]

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  15. Time of Maximum Plasma Concentration (Tmax) of fructose [Day 28]

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

  16. Area Under the Curve (AUC) of glucagon [day 0]

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  17. Maximum Plasma Concentration (Cmax) of glucagon [day 0]

    : Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  18. Time of Maximum Plasma Concentration (Tmax) of glucagon [day 0]

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  19. Area Under the Curve (AUC) of glucagon [day 7]

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  20. Maximum Plasma Concentration (Cmax) of glucagon [day 7]

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  21. Time of Maximum Plasma Concentration (Tmax) of glucagon [Day 7]

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  22. Area Under the Curve (AUC) of glucagon [Day 14]

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  23. Maximum Plasma Concentration (Cmax) of glucagon [Day 14]

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  24. Time of Maximum Plasma Concentration (Tmax) of glucagon [Day 14]

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  25. Area Under the Curve (AUC) of glucagon [Day 21]

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  26. Maximum Plasma Concentration (Cmax) of glucagon [Day 21]

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  27. Time of Maximum Plasma Concentration (Tmax) of glucagon [Day 21]

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  28. Area Under the Curve (AUC) of glucagon [Day 28]

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

  29. Maximum Plasma Concentration (Cmax) of glucagon [Day 28]

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  30. Time of Maximum Plasma Concentration (Tmax) of glucagon [Day 28]

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

  31. Area Under the Curve (AUC) of CCK [Day 0]

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  32. Maximum Plasma Concentration (Cmax) of CCK [Day 0]

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  33. Time of Maximum Plasma Concentration (Tmax) of CCK [Day 0]

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  34. Area Under the Curve (AUC) of CCK [Day 7]

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  35. Maximum Plasma Concentration (Cmax) of CCK [Day 7]

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  36. Time of Maximum Plasma Concentration (Tmax) of CCK [Day 7]

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  37. Area Under the Curve (AUC) of CCK [Day 14]

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  38. Maximum Plasma Concentration (Cmax) of CCK [Day 14]

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  39. Time of Maximum Plasma Concentration (Tmax) of CCK [Day 14]

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  40. Area Under the Curve (AUC) of CCK [Day 21]

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  41. Maximum Plasma Concentration (Cmax) of CCK [Day 21]

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  42. Time of Maximum Plasma Concentration (Tmax) of CCK [Day 21]

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  43. Area Under the Curve (AUC) of CCK [Day 28]

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  44. Maximum Plasma Concentration (Cmax) of CCK [Day 28]

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  45. Time of Maximum Plasma Concentration (Tmax) of CCK [Day 28]

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  46. Area Under the Curve (AUC) of Grehlin [Day 0]

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  47. Maximum Plasma Concentration (Cmax) of Grehlin [Day 0]

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  48. Time of Maximum Plasma Concentration (Tmax) of Grehlin [day 0]

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  49. Area Under the Curve (AUC) of Grehlin [day 7]

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  50. Maximum Plasma Concentration (Cmax) of Grehlin [day 7]

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  51. Time of Maximum Plasma Concentration (Tmax) of Grehlin [day 7]

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  52. Area Under the Curve (AUC) of Grehlin [day 14]

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  53. Maximum Plasma Concentration (Cmax) of Grehlin [day 14]

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  54. Time of Maximum Plasma Concentration (Tmax) of Grehlin [day 14]

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  55. Area Under the Curve (AUC) of Grehlin [day 21]

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  56. Maximum Plasma Concentration (Cmax) of Grehlin [day 21]

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  57. Time of Maximum Plasma Concentration (Tmax) of Grehlin [day 21]

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  58. Area Under the Curve (AUC) of Grehlin [day 28]

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  59. Maximum Plasma Concentration (Cmax) of Grehlin [day 28]

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  60. Time of Maximum Plasma Concentration (Tmax) of Grehlin [day 28]

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  61. Area Under the Curve (AUC) of leptin [day 0]

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  62. Maximum Plasma Concentration (Cmax) of leptin [day 0]

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  63. Time of Maximum Plasma Concentration (Tmax) of leptin [day 0]

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  64. Area Under the Curve (AUC) of leptin [day 7]

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  65. Maximum Plasma Concentration (Cmax) of leptin [day 7]

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  66. Time of Maximum Plasma Concentration (Tmax) of leptin [day 7]

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  67. Area Under the Curve (AUC) of leptin [day 14]

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  68. Maximum Plasma Concentration (Cmax) of leptin [day 14]

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  69. Time of Maximum Plasma Concentration (Tmax) of leptin [day 14]

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  70. Area Under the Curve (AUC) of leptin [day 21]

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  71. Maximum Plasma Concentration (Cmax) of leptin [day 21]

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  72. Time of Maximum Plasma Concentration (Tmax) of leptin [day 21]

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  73. Area Under the Curve (AUC) of leptin [day 28]

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

  74. Maximum Plasma Concentration (Cmax) of leptin [day 28]

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  75. Time of Maximum Plasma Concentration (Tmax) of leptin [day 28]

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

  76. Area Under the Curve (AUC) of GLP1 [day 0]

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

  77. Maximum Plasma Concentration (Cmax) of GLP1 [day 0]

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  78. Time of Maximum Plasma Concentration (Tmax) of GLP1 [day 0]

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  79. Area Under the Curve (AUC) of GLP1 [day 7]

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  80. Maximum Plasma Concentration (Cmax) of GLP1 [day 7]

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  81. Time of Maximum Plasma Concentration (Tmax) of GLP1 [day 7]

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  82. Area Under the Curve (AUC) of GLP1 [day 14]

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  83. Maximum Plasma Concentration (Cmax) of GLP1 [day 14]

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  84. Time of Maximum Plasma Concentration (Tmax) of GLP1 [day 14]

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  85. Area Under the Curve (AUC) of GLP1 [day 21]

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

  86. Maximum Plasma Concentration (Cmax) of GLP1 [day 21]

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  87. Time of Maximum Plasma Concentration (Tmax) of GLP1 [day 21]

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  88. Area Under the Curve (AUC) of GLP1 [day 28]

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  89. Maximum Plasma Concentration (Cmax) of GLP1 [day 28]

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

  90. Time of Maximum Plasma Concentration (Tmax) of GLP1 [day 28]

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

  91. Area Under the Curve (AUC) of incretines [day 0]

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  92. Maximum Plasma Concentration (Cmax) of incretines [day 0]

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  93. Time of Maximum Plasma Concentration (Tmax) of incretines [day 0]

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  94. Area Under the Curve (AUC) of incretines [day 7]

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  95. Maximum Plasma Concentration (Cmax) of incretines [day 7]

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  96. Time of Maximum Plasma Concentration (Tmax) of incretines [day 7]

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  97. Area Under the Curve (AUC) of incretines [day 14]

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  98. Maximum Plasma Concentration (Cmax) of incretines [day 14]

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  99. Time of Maximum Plasma Concentration (Tmax) of incretines [day 14]

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  100. Area Under the Curve (AUC) of incretines [day 21]

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  101. Maximum Plasma Concentration (Cmax) of incretines [day 21]

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  102. Time of Maximum Plasma Concentration (Tmax) of incretines [day 21]

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  103. Area Under the Curve (AUC) of incretines [day 28]

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  104. Maximum Plasma Concentration (Cmax) of incretines [day 28]

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

  105. Time of Maximum Plasma Concentration (Tmax) of incretines [day 28]

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

  106. Area Under the Curve (AUC) of insulin [day 0]

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  107. Maximum Plasma Concentration (Cmax) of insulin [day 0]

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  108. Time of Maximum Plasma Concentration (Tmax) of insulin [day 0]

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  109. Area Under the Curve (AUC) of insulin [day 7]

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  110. Maximum Plasma Concentration (Cmax) of insulin [day 7]

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  111. Time of Maximum Plasma Concentration (Tmax) of insulin [day 7]

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  112. Area Under the Curve (AUC) of insulin [day 14]

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  113. Maximum Plasma Concentration (Cmax) of insulin [day 14]

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  114. Time of Maximum Plasma Concentration (Tmax) of insulin [day 14]

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  115. Area Under the Curve (AUC) of insulin [day 21]

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  116. Maximum Plasma Concentration (Cmax) of insulin [day 21]

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  117. Time of Maximum Plasma Concentration (Tmax) of insulin [day 21]

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  118. Area Under the Curve (AUC) of insulin [day 28]

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  119. Maximum Plasma Concentration (Cmax) of urea [day 28]

    Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

  120. Time of Maximum Plasma Concentration (Tmax) of insulin [day 28]

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

  121. Area Under the Curve (AUC) of urea [day 0]

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  122. Maximum Plasma Concentration (Cmax) of urea [day 0]

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  123. Time of Maximum Plasma Concentration (Tmax) of urea [day 0]

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  124. Area Under the Curve (AUC) of urea [day 7]

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  125. Maximum Plasma Concentration (Cmax) of urea [day 7]

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  126. Time of Maximum Plasma Concentration (Tmax) of urea [day 7]

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  127. Area Under the Curve (AUC) of urea [day 14]

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  128. Maximum Plasma Concentration (Cmax) of urea [day 14]

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  129. Time of Maximum Plasma Concentration (Tmax) of urea [day 14]

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  130. Area Under the Curve (AUC) of urea [day 21]

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  131. Maximum Plasma Concentration (Cmax) of urea [day 21]

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  132. Time of Maximum Plasma Concentration (Tmax) of urea [day 21]

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  133. Area Under the Curve (AUC) of urea [day 28]

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  134. Maximum Plasma Concentration (Cmax) of urea [day 28]

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

  135. Time of Maximum Plasma Concentration (Tmax) of urea [day 28]

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

  136. Questionnaire of satiety [at time 0 after ingestion in Day 0]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  137. Questionnaire of satiety [at time 60 after ingestion in Day 0]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  138. Questionnaire of satiety [at time 180 after ingestion in Day 0]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  139. Questionnaire of satiety [at time 0 after ingestion in Day 7]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  140. Questionnaire of satiety [at time 60 after ingestion in Day 7]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  141. Questionnaire of satiety [at time 180 after ingestion in Day 7]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  142. Questionnaire of satiety [at time 0 after ingestion in Day 14]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  143. Questionnaire of satiety [at time 60 after ingestion in Day 14]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  144. Questionnaire of satiety [at time 180 after ingestion in Day 14]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

  145. Questionnaire of satiety [at time 0 after ingestion in Day 21]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  146. Questionnaire of satiety [at time 60 after ingestion in Day 21]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  147. Questionnaire of satiety [at time 180 after ingestion in Day 21]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  148. Questionnaire of satiety [at time 0 after ingestion in Day 28]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  149. Questionnaire of satiety [at time 60 after ingestion in Day 28]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  150. Questionnaire of satiety [at time 180 after ingestion in Day 28]

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

  151. Questionnaire of acceptability [day 0]

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  152. Questionnaire of acceptability [day 7]

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  153. Questionnaire of acceptability [day 14]

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  154. Questionnaire of acceptability [day 21]

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  155. Questionnaire of acceptability [day 28]

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

  156. Facilited individual interview [day 40]

    Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort

  157. Focus group [day 40]

    Focus group interview to assess organoleptic, satiety and gastrointestinal comfort

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Male subject

  • Subject over 65 years (included)

  • Subject over 61 kg (included)

  • Able to consume the 80g of fruit pastes in 10 minutes

  • Subject with a dentition consistent with the fruit paste consumption in 10 minutes

  • Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2

  • Subject agreeing to provide written consent

Exclusion Criteria:
  • Subject with acute pathology (unstable or terminal pathology, severe dementia)

  • Subject with renal failure (clearance < 60 ml/min)

  • Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)

  • Person with diabetes

  • Subject on food restriction

  • Subject undergoing chemotherapy

  • Subject with gastrointestinal pathology

  • Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Clermont-Ferrand Clermont-Ferrand France 63000

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand
  • Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
  • Unité de recherche CSGA, INRAE Dijon

Investigators

  • Principal Investigator: Gisèle Pickering, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT04482530
Other Study ID Numbers:
  • RBHP 2019 PICKERING
  • 2019-A00995-52
First Posted:
Jul 22, 2020
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2021