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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04788069
Other study ID # S64824
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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