Clinical trial NCT04788069: Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal
Official title: Effect of Sourdough Breads Consumption on Postprandial Responses, Satiety and Food Intake at Subsequent Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Intake
Appetite Regulation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Appetite measurements
timeFrame: During test day 1 (up to 4 hours)
measure: Appetite measurements
timeFrame: During test day 2 (up to 4 hours)
measure: Appetite measurements
timeFrame: During test day 3 (up to 4 hours)
measure: Food intake at subsequent meal
timeFrame: During test day 1 (240 minutes after ingestion of breakfast)
measure: Food intake at subsequent meal
timeFrame: During test day 2 (240 minutes after ingestion of breakfast)
measure: Food intake at subsequent meal
timeFrame: During test day 3 (240 minutes after ingestion of breakfast)
Secondary outcomes:
measure: Oral processing behaviour
timeFrame: During test day 1 (up to 15 minutes)
measure: Oral processing behaviour
timeFrame: During test day 2 (up to 15 minutes)
measure: Oral processing behaviour
timeFrame: During test day 3 (up to 15 minutes)
measure: Blood lipids
timeFrame: During test day 1
measure: Blood lipids
timeFrame: During test day 2
measure: Blood lipids
timeFrame: During test day 3
measure: Glucose response
timeFrame: During test day 1 (up to 4 hours)
measure: Glucose response
timeFrame: During test day 2 (up to 4 hours)
measure: Glucose response
timeFrame: During test day 3 (up to 4 hours)
measure: Insulin response
timeFrame: During test day 1 (up to 4 hours)
measure: Insulin response
timeFrame: During test day 2 (up to 4 hours)
measure: Insulin response
timeFrame: During test day 3 (up to 4 hours)
measure: Incretin hormones
timeFrame: During test day 1 (up to 4 hours)
measure: Incretin hormones
timeFrame: During test day 2 (up to 4 hours)
measure: Incretin hormones
timeFrame: During test day 3 (up to 4 hours)
measure: Short-chain-fatty-acids
timeFrame: During test day 1 (up to 8 hours)
measure: Short-chain-fatty-acids
timeFrame: During test day 2 (up to 8 hours)
measure: Short-chain-fatty-acids
timeFrame: During test day 3 (up to 8 hours)
measure: Short-chain-fatty-acids
timeFrame: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
measure: Gastric emptying rate
timeFrame: During test day 1 (up to 4 hours)
measure: Gastric emptying rate
timeFrame: During test day 2 (up to 4 hours)
measure: Gastric emptying rate
timeFrame: During test day 3 (up to 4 hours)
measure: Free-living energy intake
timeFrame: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
measure: Stool shape and consistency
timeFrame: 4 days during intervention with each bread type (totally 3x4 days over a period of 10 weeks)
measure: Change in Gut microbiota composition
timeFrame: 1 time after intervention with each bread type (totally 3 times over a period of 10 weeks)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/ UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, Prof.
role: PRINCIPAL_INVESTIGATOR
References: