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

NCT ID: NCT04788069

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-02-05

Brief Summary

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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

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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.

Conditions

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Energy Intake Appetite Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Wholemeal bread

Treatment with wholemeal bread

Group Type ACTIVE_COMPARATOR

Wholemeal bread

Intervention Type DIETARY_SUPPLEMENT

180g wholemeal bread/day + fixed portion at test day

Sourdough bread

Treatment with sourdough bread

Group Type ACTIVE_COMPARATOR

Sourdough bread

Intervention Type DIETARY_SUPPLEMENT

180g sourdough bread/day + fixed portion at test day

Bread with sourdough

Treatment with bread with sourdough

Group Type ACTIVE_COMPARATOR

Bread with sourdough

Intervention Type DIETARY_SUPPLEMENT

180g bread with sourdough/day + fixed portion at test day

Interventions

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Wholemeal bread

180g wholemeal bread/day + fixed portion at test day

Intervention Type DIETARY_SUPPLEMENT

Sourdough bread

180g sourdough bread/day + fixed portion at test day

Intervention Type DIETARY_SUPPLEMENT

Bread with sourdough

180g bread with sourdough/day + fixed portion at test day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Verbeke, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S64824

Identifier Type: -

Identifier Source: org_study_id

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