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

Energy Intake Clinical Trial

— SUPPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788069
• Other study ID #: S64824
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: February 5, 2024

Study information

• Verified date: May 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Appetite Regulation
• Energy Intake

Intervention

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

Locations

Country	Name	City	State
Belgium	KU Leuven/ UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Blood lipids	Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically	During test day 1
Secondary	Blood lipids	Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically	During test day 2
Secondary	Blood lipids	Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically	During test day 3
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Short-chain-fatty-acids	Faecal (GC-FID)	1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)