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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Energy Intake, Appetite Regulation

Intervention / Treatment
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* Dietary Supplement: Wholemeal bread
* Dietary Supplement: Sourdough bread
* Dietary Supplement: Bread with sourdough


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wholemeal bread<br>Treatment with wholemeal bread | Dietary Supplement: Wholemeal bread<br>* 180g wholemeal bread/day + fixed portion at test day<br>|
| Active Comparator: Sourdough bread<br>Treatment with sourdough bread | Dietary Supplement: Sourdough bread<br>* 180g sourdough bread/day + fixed portion at test day<br>|
| Active Comparator: Bread with sourdough<br>Treatment with bread with sourdough | Dietary Supplement: Bread with sourdough<br>* 180g bread with sourdough/day + fixed portion at test day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite measurements | 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). | During test day 1 (up to 4 hours) | 
| Appetite measurements | 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). | During test day 2 (up to 4 hours) | 
| Appetite measurements | 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). | During test day 3 (up to 4 hours) | 
| Food intake at subsequent meal | Weighted amounts of ad-libitum food offered minus the weighted leftovers | During test day 1 (240 minutes after ingestion of breakfast) | 
| Food intake at subsequent meal | Weighted amounts of ad-libitum food offered minus the weighted leftovers | During test day 2 (240 minutes after ingestion of breakfast) | 
| Food intake at subsequent meal | Weighted amounts of ad-libitum food offered minus the weighted leftovers | During test day 3 (240 minutes after ingestion of breakfast) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral processing behaviour | Participants will be video-recorded to measure oral processing behaviour of the test meal | During test day 1 (up to 15 minutes) | 
| Oral processing behaviour | Participants will be video-recorded to measure oral processing behaviour of the test meal | During test day 2 (up to 15 minutes) | 
| Oral processing behaviour | Participants will be video-recorded to measure oral processing behaviour of the test meal | During test day 3 (up to 15 minutes) | 
| Blood lipids | Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically | During test day 1 | 
| Blood lipids | Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically | During test day 2 | 
| Blood lipids | Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically | During test day 3 | 
| Glucose response | 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) | During test day 1 (up to 4 hours) | 
| Glucose response | 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) | During test day 2 (up to 4 hours) | 
| Glucose response | 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) | During test day 3 (up to 4 hours) | 
| Insulin response | 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). | During test day 1 (up to 4 hours) | 
| Insulin response | 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). | During test day 2 (up to 4 hours) | 
| Insulin response | 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). | During test day 3 (up to 4 hours) | 
| Incretin hormones | 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). | During test day 1 (up to 4 hours) | 
| Incretin hormones | 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). | During test day 2 (up to 4 hours) | 
| Incretin hormones | 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). | During test day 3 (up to 4 hours) | 
| Short-chain-fatty-acids | 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). | During test day 1 (up to 8 hours) | 
| Short-chain-fatty-acids | 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). | During test day 2 (up to 8 hours) | 
| Short-chain-fatty-acids | 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). | During test day 3 (up to 8 hours) | 
| Short-chain-fatty-acids | Faecal (GC-FID) | 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks) | 
| Gastric emptying rate | 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). | During test day 1 (up to 4 hours) | 
| Gastric emptying rate | 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). | During test day 2 (up to 4 hours) | 
| Gastric emptying rate | 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). | During test day 3 (up to 4 hours) | 
| Free-living energy intake | 4-day food diaries, mobile app | 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks) | 
| Stool shape and consistency | 4-day stool diaries, the Bristol Stool Score | 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks) | 
| Change in Gut microbiota composition | 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 | 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks) |