SUPPRESS: Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal

Sponsor
KU Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04788069
Collaborator
(none)
54
1
3
23
2.4

Study Details

Study Description

Brief Summary

During this project the effect of different types of sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Wholemeal bread
  • Dietary Supplement: Sourdough bread
  • Dietary Supplement: Bread with sourdough
N/A

Detailed Description

A 3-phase randomised cross-over trial will be applied consisting of 3 intervention periods of 2 weeks, with a test day performed at the last day of each intervention period. During each intervention period, participants will consume a fixed amount of test bread, replacing their regular bread, and they will keep food and stool diaries preceding each Test-day. Faecal samples will be collected before each Test-day. On the Test-day, participants will perform a gastric emptying breath test. Furthermore, blood samples and appetite ratings will be collected at regular time points after consumption of the test bread for measurement of glucose, insulin, gut peptides, short-chain fatty acids (SCFA) and blood lipids. Food intake will be assessed by offering the subjects a standard lunch to be consumed ad-libitum.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wholemeal bread

Treatment with wholemeal bread

Dietary Supplement: Wholemeal bread
180g wholemeal bread/day + fixed portion at test day

Active Comparator: Sourdough bread

Treatment with sourdough bread

Dietary Supplement: Sourdough bread
180g sourdough bread/day + fixed portion at test day

Active Comparator: Bread with sourdough

Treatment with bread with sourdough

Dietary Supplement: Bread with sourdough
180g bread with sourdough/day + fixed portion at test day

Outcome Measures

Primary Outcome Measures

  1. Appetite measurements [During test day 1 (up to 4 hours)]

    Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  2. Appetite measurements [During test day 2 (up to 4 hours)]

    Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  3. Appetite measurements [During test day 3 (up to 4 hours)]

    Appetite in response to test meal, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS) before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  4. Food intake at subsequent meal [During test day 1 (240 minutes after ingestion of breakfast)]

    Weighted amounts of ad-libitum food offered minus the weighted leftovers

  5. Food intake at subsequent meal [During test day 2 (240 minutes after ingestion of breakfast)]

    Weighted amounts of ad-libitum food offered minus the weighted leftovers

  6. Food intake at subsequent meal [During test day 3 (240 minutes after ingestion of breakfast)]

    Weighted amounts of ad-libitum food offered minus the weighted leftovers

Secondary Outcome Measures

  1. Oral processing behaviour [During test day 1 (up to 15 minutes)]

    Participants will be video-recorded to measure oral processing behaviour of the test meal

  2. Oral processing behaviour [During test day 2 (up to 15 minutes)]

    Participants will be video-recorded to measure oral processing behaviour of the test meal

  3. Oral processing behaviour [During test day 3 (up to 15 minutes)]

    Participants will be video-recorded to measure oral processing behaviour of the test meal

  4. Blood lipids [During test day 1]

    Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

  5. Blood lipids [During test day 2]

    Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

  6. Blood lipids [During test day 3]

    Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

  7. Glucose response [During test day 1 (up to 4 hours)]

    Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)

  8. Glucose response [During test day 2 (up to 4 hours)]

    Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)

  9. Glucose response [During test day 3 (up to 4 hours)]

    Blood glucose response will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes)

  10. Insulin response [During test day 1 (up to 4 hours)]

    Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  11. Insulin response [During test day 2 (up to 4 hours)]

    Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  12. Insulin response [During test day 3 (up to 4 hours)]

    Blood C-peptide (as indicator of insulin response) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  13. Incretin hormones [During test day 1 (up to 4 hours)]

    Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  14. Incretin hormones [During test day 2 (up to 4 hours)]

    Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  15. Incretin hormones [During test day 3 (up to 4 hours)]

    Incretin hormones (GLP-1 and PYY) will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240 minutes).

  16. Short-chain-fatty-acids [During test day 1 (up to 8 hours)]

    Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).

  17. Short-chain-fatty-acids [During test day 2 (up to 8 hours)]

    Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).

  18. Short-chain-fatty-acids [During test day 3 (up to 8 hours)]

    Short-chain-fatty-acids will be measured through blood samples collected via placed catheter before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480 minutes).

  19. Short-chain-fatty-acids [1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)]

    Faecal (GC-FID)

  20. Gastric emptying rate [During test day 1 (up to 4 hours)]

    Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  21. Gastric emptying rate [During test day 2 (up to 4 hours)]

    Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  22. Gastric emptying rate [During test day 3 (up to 4 hours)]

    Gastric emptying rate will be measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after completion of test meal (I.e. 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes).

  23. Free-living energy intake [4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)]

    4-day food diaries, mobile app

  24. Stool shape and consistency [4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)]

    4-day stool diaries, the Bristol Stool Score

  25. Change in Gut microbiota composition [1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)]

    Change in Gut microbiota composition after consumption of each test meal for 14 days will be analysed using the relative abundance of bacterial taxa according to 16S rRNA sequencing data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Female and male participants

  • age range 18 - 50

  • BMI range 18.5 - 25.0 kg/m2 at screening visit

  • Regular eating pattern (3 meals per day on at least 5 days per week)

  • Willingness to consume bread (180 g) on a daily base

  • Stable body weight for the last 6 months

Exclusion Criteria:
  • Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period

  • Pregnancy, lactation or wish to become pregnant during the study period

  • Family history of diabetes

  • Previous or current gastrointestinal or endocrine disorders

  • Previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)

  • Intake of prescription medication

  • Coeliac disease or gluten sensitivity

  • Use of pre- or probiotics within one month preceding the study

  • Use of antibiotics within 3 months preceding the study

  • Excessive concern about eating habits or body weight as evidenced from scores < 10 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard & Messick, 1985)

Contacts and Locations

Locations

Site City State Country Postal Code
1 KU Leuven/ UZ Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • KU Leuven

Investigators

  • Principal Investigator: Kristin Verbeke, Prof., KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kristin Verbeke, Principal Investigator, KU Leuven
ClinicalTrials.gov Identifier:
NCT04788069
Other Study ID Numbers:
  • S64824
First Posted:
Mar 9, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 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

Study Results

No Results Posted as of Aug 3, 2022