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Completed

NCT Number: NCT04788069

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

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.

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Key information

Conditions

Energy Intake Appetite Regulation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 < 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard & Messick, 1985)

Treatment and study plan

Wholemeal bread

Dietary Supplement

180g wholemeal bread/day + fixed portion at test day

Sourdough bread

Dietary Supplement

180g sourdough bread/day + fixed portion at test day

Bread with sourdough

Dietary Supplement

180g bread with sourdough/day + fixed portion at test day

Primary outcomes

  1. Appetite measurements

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During test day 3 (240 minutes after ingestion of breakfast)

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

Secondary outcomes

  1. Oral processing behaviour

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During test day 1

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

  5. Blood lipids

    Time frame: During test day 2

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

  6. Blood lipids

    Time frame: During test day 3

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

  7. Glucose response

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)

    Faecal (GC-FID)

  20. Gastric emptying rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: SUPPRESS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2021
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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