Clinical trial NCT06015867: Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake
Official title: Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Satiety
Energy Intake
Glucose Response
Insulin Response
Gastric Emptying
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: During this project the effect of yeast bread and sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.

Detailed description: The primary aim of this study will be to evaluate the impact of an alternative starter culture that produces high levels of lactic acid on appetite regulation (subjective satiety and energy intake at the subsequent meal). The second aim will be to identify mechanistic parameters that may explain the observed effects, including glycaemic and insulin response, and gastric emptying rate. In addition, habitual physical activity levels, and mood and stress levels of the subjects will be evaluated as potential covariates of appetite regulation.

It is hypothesized that:

Sourdough breads fermented with the alternative starter culture that produce high concentrations of lactic acid will reduce glucose response via lower starch digestibility and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher satiety and lower energy intake at the subsequent meal (more than 10%).

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)
* 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)
* 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: 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)
Secondary outcomes:
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: Insulin response
timeFrame: During test day 1 (up to 4 hours)
measure: Insulin response
timeFrame: During test day 2 (up to 4 hours)
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: Subjective stress ratings
timeFrame: During test day 1 (up to 4 hours)
measure: Subjective stress ratings
timeFrame: During test day 2 (up to 4 hours)
measure: Physical activity questionnaire
timeFrame: At the end of test day 1
measure: Physical activity questionnaire
timeFrame: At the end of test day 2
measure: Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
timeFrame: At the end of test day 1
measure: Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)
timeFrame: At the end of test day 2
measure: Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
timeFrame: At the end of test day 1
measure: Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)
timeFrame: At the end of test day 2
measure: Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
timeFrame: At the end of test day 1
measure: Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)
timeFrame: At the end of test day 2
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZ Leuven
state: Vlaams Brabant
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, PhD
role: PRINCIPAL_INVESTIGATOR
References: