The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype

Sponsor
Wageningen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05456815
Collaborator
(none)
63
1
1
3.7
17.1

Study Details

Study Description

Brief Summary

Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet and phenotype in postprandial glucose responses is unclear.

The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.

63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years will be included in the study, comprising a characterization period of 3 weeks and a completely controlled dietary intervention of 9 weeks. During these 9 weeks, glucose will be continuously monitored to measure postprandial glucose responses to standard foods/meals.

There are minor risks for the research subjects of this study. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.

Condition or Disease Intervention/Treatment Phase
  • Other: Standardized diet
N/A

Detailed Description

Postprandial glucose responses are related to an increased risk of developing cardiometabolic diseases. Existing research recognizes the presence of inter-individual variation in postprandial glucose responses to the same meal or food product. However, the role of diet, i.e. the other consumed food products and meals, and phenotype in postprandial glucose responses is unclear. A repetitive design and a standardized diet are necessary to determine the variation in postprandial glucose responses to a meal or food product irrespective of the diet.

The primary objective of this study is to determine the variation in postprandial glucose responses to the same meals/food products and how this relates to the variation in postprandial glucose responses over a 9-week fully controlled dietary intervention within individuals. Our secondary objectives are to investigate the difference between postprandial glucose responses to original products and postprandial glucose responses to reformulated products, and to examine the relation between postprandial glucose responses and short-term well-being. In addition, we aim to study the relation between variation in postprandial glucose and phenotype, including immune function, cognitive performance, and microbiota composition.

The study population consists of 63 apparently healthy men and women with a BMI of 25-40 kg/m2, aged 45-75 years, and who are weight stable (± <3 kg) for at least three months prior to inclusion.

The study comprises a characterization period of three weeks, followed by a fully controlled dietary intervention trial of nine weeks. In the characterization period, the phenotype of participants will be determined by measures on anthropometrics, immune function, oxidative stress, advanced glycation end-products, cognitive performance, microbiota and gut health, amylase, genetics, and circulating metabolites. The dietary intervention consists of three repetitive rounds of three weeks, in which we test food products in a cross-over setting. Participants will consume test products that fall in the same food category, but differ in glycaemic index/carbohydrate content. Part of these products is provided by industrial partners, of which the original products are reformulated to be reduced in glycaemic index/carbohydrate content. During the 9-week dietary intervention all foods are provided, giving us a complete and detailed picture of food and nutrient intake during this period. The standardized diet follows the average consumption pattern of the study population. Throughout the intervention, interstitial glucose concentrations will be measured using continuous glucose monitoring (CGM) and physical activity will be monitored with an accelerometer.

This study is related to a broad general population. There are minor risks for the research subjects of this study. Placing a continuous glucose sensor generally does not cause pain, but could result in the loss of a drop of blood, or slight skin irritation after wearing. Blood sampling will be performed via a cannula or venapunction and the insertion can be a bit painful and may cause a bruise. During the characterization period, in total 215 mL of blood will be collected in a 3-week timespan. In the following 9 weeks 108 mL, and at the end of the intervention 34 mL blood will be collected. Research subjects will invest approximately 85 hours in the study. During the characterization week, subjects will visit the Wageningen University 3 times and Hospital Gelderse Vallei (Ede, The Netherlands) once. During the controlled dietary intervention, subjects will visit the Wageningen University 2-3 times a week.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Investigational products will be provided in a standardized environment.Investigational products will be provided in a standardized environment.
Masking:
None (Open Label)
Masking Description:
Test products will be provided by the "care provider"/dietician. All others will be blinded during the trial.
Primary Purpose:
Prevention
Official Title:
The RepEAT Study: Individual Differences in Postprandial Glucose Responses and the Relation With Diet and Phenotype
Anticipated Study Start Date :
Aug 26, 2022
Anticipated Primary Completion Date :
Dec 16, 2022
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Standardized diet

Standardized food products/meals will be tested

Other: Standardized diet
During 9 weeks all food products will be standardized and provided by the Research Unit. The standardized diet is based on the average food composition in the Netherlands.
Other Names:
  • 9-week fully controlled dietary intervention
  • Outcome Measures

    Primary Outcome Measures

    1. Blood glucose profile [Continuous for 9 weeks]

      Interstitial glucose concentrations, as measured by continuous glucose monitoring

    Secondary Outcome Measures

    1. Short-term well-being [Baseline]

      Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

    2. Short-term well-being [1 hour post-ingestion]

      Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

    3. Short-term well-being [2 hours post-ingestion]

      Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

    4. Short-term well-being [4 hours post-ingestion]

      Short-term well-being upon investigational product consumption assessed by the Multidimensional Mood Questionnaire (MDMQ)

    5. Postprandial glucose blood levels [Baseline]

      Postprandial glucose responses in blood upon a mixed meal challenge

    6. Postprandial glucose blood levels [30 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    7. Postprandial glucose blood levels [60 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    8. Postprandial glucose blood levels [90 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    9. Postprandial glucose blood levels [120 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    10. Postprandial glucose blood levels [180 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    11. Postprandial glucose blood levels [240 minutes post-ingestion]

      Postprandial glucose responses in blood upon a mixed meal challenge

    12. Postprandial insulin blood levels [Baseline]

      Postprandial insulin responses in blood upon a mixed meal challenge

    13. Postprandial insulin blood levels [30 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    14. Postprandial insulin blood levels [60 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    15. Postprandial insulin blood levels [90 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    16. Postprandial insulin blood levels [120 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    17. Postprandial insulin blood levels [180 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    18. Postprandial insulin blood levels [240 minutes post-ingestion]

      Postprandial insulin responses in blood upon a mixed meal challenge

    19. Postprandial metabolite blood levels [Baseline]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    20. Postprandial metabolite blood levels [30 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    21. Postprandial metabolite blood levels [60 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    22. Postprandial metabolite blood levels [90 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    23. Postprandial metabolite blood levels [120 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    24. Postprandial metabolite blood levels [180 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    25. Postprandial metabolite blood levels [240 minutes post-ingestion]

      Postprandial responses in blood upon a mixed meal challenge as measured by metabolomics

    26. Postprandial lipid profiling [Baseline]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    27. Postprandial lipid profiling [30 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    28. Postprandial lipid profiling [60 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    29. Postprandial lipid profiling [90 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    30. Postprandial lipid profiling [120 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    31. Postprandial lipid profiling [180 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    32. Postprandial lipid profiling [240 minutes post-ingestion]

      Postprandial lipid profiling in blood upon a mixed meal challenge

    33. Postprandial fatty acid blood levels [Baseline]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    34. Postprandial fatty acid blood levels [30 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    35. Postprandial fatty acid blood levels [60 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    36. Postprandial fatty acid blood levels [90 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    37. Postprandial fatty acid blood levels [120 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    38. Postprandial fatty acid blood levels [180 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    39. Postprandial fatty acid blood levels [240 minutes post-ingestion]

      Postprandial fatty acid concentrations in blood upon a mixed meal challenge

    40. Postprandial gut hormone blood levels [Baseline]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    41. Postprandial gut hormone blood levels [30 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    42. Postprandial gut hormone blood levels [60 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    43. Postprandial gut hormone blood levels [90 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    44. Postprandial gut hormone blood levels [120 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    45. Postprandial gut hormone blood levels [180 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    46. Postprandial gut hormone blood levels [240 minutes post-ingestion]

      Postprandial gut hormone concentrations in blood upon a mixed meal challenge

    47. Cholesterol concentration [Baseline]

      Fasting plasma cholesterol concentration

    48. Postprandial blood glucose levels [Baseline]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    49. Postprandial blood glucose levels [15 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    50. Postprandial blood glucose levels [30 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    51. Postprandial blood glucose levels [45 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    52. Postprandial blood glucose levels [60 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    53. Postprandial blood glucose levels [90 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    54. Postprandial blood glucose levels [120 minutes post-ingestion]

      Postprandial glucose responses in blood upon an oral glucose tolerance test

    55. Postprandial blood insulin levels [Baseline]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    56. Postprandial blood insulin levels [15 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    57. Postprandial blood insulin levels [30 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    58. Postprandial blood insulin levels [45 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    59. Postprandial blood insulin levels [60 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    60. Postprandial blood insulin levels [90 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    61. Postprandial blood insulin levels [120 minutes post-ingestion]

      Postprandial insulin responses in blood upon an oral glucose tolerance test

    62. Physical activity [Continuous for 9 weeks]

      Continuous physical activity levels, measured by the Actigraph accelerometer wGT3X-BT (ActiGraph, Pensacola, USA)

    63. Physical activity [Continuous for 3 non-consecutive weeks between week 1 and week 9 of the dietary intervention]

      Continuous physical activity levels, measured by ActivPAL3 micro (PAL Technologies, Glasgow, Scotland) during 3 non-consecutive weeks

    64. Body fat distribution [Baseline]

      Ratio between visceral and subcutaneous adipose tissue as measured by magnetic resonance imaging (MRI)

    65. Liver fat content [Baseline]

      Liver fat content as measured by MRS

    66. HbA1c [Baseline]

      HbA1c

    67. Fasting glucose concentration [Baseline]

      Fasting glucose concentration

    68. Fasting insulin concentration [Baseline]

      Fasting insulin concentration

    69. Circulating cytokines [Baseline]

      Circulating plasma cytokines

    70. PBMC composition [Baseline]

      Immune function as measured by PBMC composition

    71. PBMC composition [End of intervention (week 12)]

      Immune function as measured by PBMC composition

    72. Metabolism immune cell populations [Baseline]

      Metabolism of immune cell populations as measured by SCENITH

    73. Immune function [End of intervention (week 12)]

      Metabolism of immune cell populations as measured by SCENITH

    74. Immune response [Baseline]

      Immune response upon TLR stimulation

    75. Immune response [End of intervention (week 12)]

      Immune response upon TLR stimulation

    76. PBMC cytokine production [Baseline]

      PBMC cytokine production as measured by intracellular staining

    77. PBMC cytokine production [End of intervention (week 12)]

      PBMC cytokine production as measured by intracellular staining

    78. Oxidative stress marker urine [Baseline]

      Oxidative stress as measured by free 8-iso PGF2a in urine

    79. Oxidative stress marker urine [End of intervention (week 12)]

      Oxidative stress as measured by free 8-iso PGF2a in urine

    80. Oxidative stress in plasma [Baseline]

      Oxidative stress as measured by MDA levels in plasma

    81. Oxidative stress in plasma [End of intervention (week 12)]

      Oxidative stress as measured by MDA levels in plasma

    82. Oxidative stress in plasma [Baseline]

      Oxidative stress as measured by nitrotyrosine in plasma

    83. Oxidative stress in plasma [End of intervention (week 12)]

      Oxidative stress as measured by nitrotyrosine in plasma

    84. Advanced glycation end-products (AGEs) blood [Baseline]

      AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

    85. Advanced glycation end-products (AGEs) blood [End of intervention (week 12)]

      AGE concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

    86. Alpha-dicarbonyl concentrations blood [Baseline]

      alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

    87. Alpha-dicarbonyl concentrations blood [End of intervention (week 12)]

      alpha-dicarbonyl concentrations in plasma as measured by ultraperformance liquid chromatography-tandem mass spectrometry

    88. AGE accumulation [Baseline]

      Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)

    89. AGE accumulation [End of intervention (week 12)]

      Accumulation of AGEs in the skin as measured by an AGE reader (Diagnoptics, Groningen, the Netherlands)

    90. Cognitive performance [Baseline]

      Cognitive performance as measured by the Cambridge Neuropsychological Test Automated Battery

    91. Oral microbiota composition [Baseline]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    92. Oral microbiota composition [Week 1 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    93. Oral microbiota composition [Week 2 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    94. Oral microbiota composition [Week 3 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    95. Oral microbiota composition [Week 4 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    96. Oral microbiota composition [Week 5 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    97. Oral microbiota composition [Week 6 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    98. Oral microbiota composition [Week 7 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    99. Oral microbiota composition [Week 8 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    100. Oral microbiota composition [Week 9 dietary intervention]

      Microbiota composition in the saliva by extracting bacterial DNA for 16S rRNA sequencing

    101. Fecal microbiota composition [Baseline]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    102. Fecal microbiota composition [Week 1 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    103. Fecal microbiota composition [Week 2 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    104. Fecal microbiota composition [Week 3 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    105. Fecal microbiota composition [Week 4 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    106. Fecal microbiota composition [Week 5 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    107. Fecal microbiota composition [Week 6 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    108. Fecal microbiota composition [Week 7 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    109. Fecal microbiota composition [Week 8 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    110. Fecal microbiota composition [Week 9 dietary intervention]

      Microbiota composition in the feces by extracting bacterial DNA for 16S rRNA sequencing

    111. Self-reported stool consistency [Baseline]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    112. Self-reported stool consistency [Week 1 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    113. Self-reported stool consistency [Week 2 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    114. Self-reported stool consistency [Week 3 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    115. Self-reported stool consistency [Week 4 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    116. Self-reported stool consistency [Week 5 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    117. Self-reported stool consistency [Week 6 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    118. Self-reported stool consistency [Week 7 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    119. Self-reported stool consistency [Week 8 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    120. Self-reported stool consistency [Week 9 dietary intervention]

      Self-reported stool consistency by using the bristol stool chart (scores between 1-7). Low scores indicate constipation and high scores diarrhea. Scores of 3-4 indicate a 'normal' stool.

    121. Transit time [Baseline]

      Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces

    122. Transit time [End of intervention (week 12)]

      Transit time, measured as the time in with blue (dietary) dye is consumed and observed in the feces

    123. Salivary amylase concentration [Baseline]

      Concentration of salivary amylase

    124. Salivary amylase concentration [End of intervention (week 12)]

      Concentration of salivary amylase

    125. Salivary amylase activity [Baseline]

      Activity of salivary amylase

    126. Salivary amylase activity [End of intervention (week 12)]

      Activity of salivary amylase

    127. Genetic variation amylase genes [Baseline]

      SNPs in genes coding for amylase, collected using a mouth swab

    128. Genetic variation metabolism and responses to food [Baseline]

      SNPs in genes relevant for metabolism and responses to food, collected using a mouth swab

    129. Habitual dietary intake [Baseline]

      Habitual dietary intake assessment with a food frequency questionnaire (FFQ)

    130. Plasma glucose response fries A [Baseline]

      Plasma glucose response to fries type A

    131. Plasma glucose response fries A [2 hours post-ingestion]

      Plasma glucose response to fries type A

    132. Plasma glucose response fries B [Baseline]

      Plasma glucose response to fries type B

    133. Plasma glucose response fries B [2 hours post-ingestion]

      Plasma glucose response to fries type B

    134. Plasma glucose response fries C [Baseline]

      Plasma glucose response to fries type C

    135. Plasma glucose response fries C [2 hours post-ingestion]

      Plasma glucose response to fries type C

    136. Plasma glucose response yoghurt A [Baseline]

      Plasma glucose response to yoghurt type A

    137. Plasma glucose response yoghurt A [2 hours post-ingestion]

      Plasma glucose response to yoghurt type A

    138. Plasma glucose response yoghurt B [Baseline]

      Plasma glucose response to yoghurt type B

    139. Plasma glucose response yoghurt B [2 hours post-ingestion]

      Plasma glucose response to yoghurt type B

    140. Plasma glucose response yoghurt C [Baseline]

      Plasma glucose response to yoghurt type C

    141. Plasma glucose response yoghurt C [2 hours post-ingestion]

      Plasma glucose response to yoghurt type C

    142. Plasma glucose response cake A [Baseline]

      Plasma glucose response to cake type A

    143. Plasma glucose response cake A [2 hours post-ingestion]

      Plasma glucose response to cake type A

    144. Plasma glucose response cake B [Baseline]

      Plasma glucose response to cake type B

    145. Plasma glucose response cake B [2 hours post-ingestion]

      Plasma glucose response to cake type B

    146. Plasma glucose response cake C [Baseline]

      Plasma glucose response to cake type C

    147. Plasma glucose response cake C [2 hours post-ingestion]

      Plasma glucose response to cake type C

    148. Plasma insulin response fries A [Baseline]

      Plasma insulin response to fries type A

    149. Plasma insulin response fries A [2 hours post-ingestion]

      Plasma insulin response to fries type A

    150. Plasma insulin response fries B [Baseline]

      Plasma insulin response to fries type B

    151. Plasma insulin response fries B [2 hours post-ingestion]

      Plasma insulin response to fries type B

    152. Plasma insulin response fries C [Baseline]

      Plasma insulin response to fries type C

    153. Plasma insulin response fries C [2 hours post-ingestion]

      Plasma insulin response to fries type C

    154. Plasma insulin response yoghurt A [Baseline]

      Plasma insulin response to yoghurt type A

    155. Plasma insulin response yoghurt A [2 hours post-ingestion]

      Plasma insulin response to yoghurt type A

    156. Plasma insulin response yoghurt B [Baseline]

      Plasma insulin response to yoghurt type B

    157. Plasma insulin response yoghurt B [2 hours post-ingestion]

      Plasma insulin response to yoghurt type B

    158. Plasma insulin response yoghurt C [Baseline]

      Plasma insulin response to yoghurt type C

    159. Plasma insulin response yoghurt C [2 hours post-ingestion]

      Plasma insulin response to yoghurt type C

    160. Plasma insulin response cake A [Baseline]

      Plasma insulin response to cake type A

    161. Plasma insulin response cake A [2 hours post-ingestion]

      Plasma insulin response to cake type A

    162. Plasma insulin response cake B [Baseline]

      Plasma insulin response to cake type B

    163. Plasma insulin response cake B [2 hours post-ingestion]

      Plasma insulin response to cake type B

    164. Plasma insulin response cake C [Baseline]

      Plasma insulin response to cake type C

    165. Plasma insulin response cake C [2 hours post-ingestion]

      Plasma insulin response to cake type C

    Other Outcome Measures

    1. Waist-to-hip ratio [Baseline]

      Waist-to-hip ratio

    2. Body mass index [Baseline]

      Body mass index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Apparently healthy men and women

    • BMI of 25 - 40 kg/m2

    • Age 45-75 years

    • Weight stable (± <3 kg) for at least two months prior to inclusion

    Exclusion Criteria:
    • Diagnosed with type 1 or type 2 diabetes

    • Diseases or prior surgeries affecting the stomach, liver, or intestines

    • Food allergies/intolerances for products used in the study design

    • Receiving medication or supplements interfering with glucose metabolism (as judged by our research physician)

    • Regular use of medication interfering with immune function (e.g. corticosteroids, immune blockers, as judged by our research physician)

    • Donated blood within 2 months prior to the screening

    • Anaemia defined as Hb concentrations <8.5 mmol/L for men and <7.5 mmol/L for women

    • Veins not suitable for venflon needle

    • Allergy/intolerance to medical skin adhesives

    • Dietary habits interfering with the study design (e.g. vegetarian, vegan, ketogenic diet)

    • Intention to change the intensity of exercise during the study period

    • Current smokers

    • Alcohol intake ≥14 alcoholic beverages per week (women) or ≥21 alcoholic beverages per week (men)

    • Being pregnant or lactating

    • Use of soft and/or hard drugs

    • Unable/unwilling to download a research application on the mobile phone

    • Participation in another study that involves an intervention within two months prior to the intervention

    • Working at the division of Human Nutrition and Health of Wageningen University and Research or the Food, Health and Consumer research group of Wageningen University and Biobased Research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wageningen University, Division of Human Nutrition Wageningen Gelderland Netherlands 6700 EV

    Sponsors and Collaborators

    • Wageningen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lydia A. Afman, Associate professor, Wageningen University
    ClinicalTrials.gov Identifier:
    NCT05456815
    Other Study ID Numbers:
    • NL80179.091.21
    First Posted:
    Jul 13, 2022
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lydia A. Afman, Associate professor, Wageningen University

    Study Results

    No Results Posted as of Jul 13, 2022