Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake

Appetite Clinical Trial

— SPAR  

Official title:

Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake at the Subsequent Meal (SPAR Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015867
• Other study ID #: S64824 - B3222020000339
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: Georgia Chatonidi, MSc
• Phone: +32 16 19 43 24
• Email: georgia.chatonidi[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 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)
• 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)

Related Conditions & MeSH terms

• Appetite
• Energy Intake
• Gastric Emptying
• Glucose Response
• Insulin Response
• Satiety

Intervention

Dietary Supplement:
• Dietary Intervention with Wholemeal Bread with Yeast
Single administration of 150g wholemeal long-time processed bread with baker's yeast, with no lactic acid (control).
• Dietary Intervention with Wholemeal Sourdough Bread
Single administration of 150g wholemeal long-time processed sourdough bread (with alternative lactic acid bacteria and yeast) high in lactic acid concentration.

Locations

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

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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).; Measurements will be taken: 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), with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).; Measurements will be taken: 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	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)
Secondary	Glucose response	Blood glucose response will be measured through blood samples collected via placed catheter before eating and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 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 and at respective time points after completion of test meal (I.e. 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 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 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	Subjective stress ratings	Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).; Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).	During test day 1 (up to 4 hours)
Secondary	Subjective stress ratings	Subjective stress, will be measured using 100 millimeter (mm) Visual Analogue Scales (VAS), with with 0 being the minimum value (not at all) and 100 being the maximum value (extremely).; Measurements will be takem: before eating (i.e. -15 minute) and at respective time points after completion of test meal (I.e. 0, 60, 120, 180, 240 minutes).	During test day 2 (up to 4 hours)
Secondary	Physical activity questionnaire	Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.	At the end of test day 1
Secondary	Physical activity questionnaire	Questionnaire about habitual physical activity over the past 1 week. Subjects will have to report how many days per week and for how many minus they perform vigorous, moderate or relaxed physical activity.	At the end of test day 2
Secondary	Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).	At the end of test day 1
Secondary	Mood related questionnaires - The Positive and Negative Affect Schedule (PANAS scale)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate the extent they have felt certain feelings over the past week. Score will vary between 1 (Very slightly or not at all) to 5 (Extremely).	At the end of test day 2
Secondary	Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).	At the end of test day 1
Secondary	Mood related questionnaires - Perceived Stress Scale - 10 items (PSS-10)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate how ofter have felt certain feelings over the past week. Score will vary between 0 (Never) to 4 (Very often).	At the end of test day 2
Secondary	Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).	At the end of test day 1
Secondary	Mood related questionnaires - Depression, Anxiety, Stress Scales - 21 items (DASS-21)	Mood related questionnaires over the past 1 week. Subjects will have to evaluate es how much the statement applied to them over the last week. Score will vary between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).	At the end of test day 2