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

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.

Study Overview

• Status: Recruiting
• Conditions: Appetite Regulation; Energy Intake
• Intervention / Treatment: Dietary supplement: Wholemeal bread; Dietary supplement: Sourdough bread; Dietary supplement: Bread with sourdough

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 Type: Interventional
• Enrollment (Estimated): 43
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Chatonidi, MSc; Phone Number: +32 16 19 43 24; Email: georgia.chatonidi@kuleuven.be
• Study Contact Backup: Name: Kristin Verbeke, Prof.; Email: kristin.verbeke@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • KU Leuven/ UZ Leuven
      • Contact: Georgia Chatonidi, MSc; Phone Number: +32 16 19 43 24; Email: georgia.chatonidi@kuleuven.be
      • Contact: Kristin Verbeke, Prof.; Email: kristin.verbeke@kuleuven.be
      • Principal Investigator: Kristin Verbeke, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: S64824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No