Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility

NCT ID: NCT05590611

Last Updated: 2023-06-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-09-30

Brief Summary

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The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.

Detailed Description

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Conditions

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Appetite Regulation Energy Intake Body Weight Changes Eating Behavior Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Brown Bread

Group Type PLACEBO_COMPARATOR

Dietary Intervention with Brown Bread

Intervention Type OTHER

The participants in this group will be asked to replace all their habitual bread intake by standard brown bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

Wholemeal Sourdough Bread

Group Type ACTIVE_COMPARATOR

Dietary Intervention with Sourdough Bread

Intervention Type OTHER

The participants in thisgroup will be asked to replace all their habitual bread intake by wholemeal sourdough bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

Interventions

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Dietary Intervention with Brown Bread

The participants in this group will be asked to replace all their habitual bread intake by standard brown bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

Intervention Type OTHER

Dietary Intervention with Sourdough Bread

The participants in thisgroup will be asked to replace all their habitual bread intake by wholemeal sourdough bread. The duration of the study for each participant is 4 weeks. Apart from the change in type of bread, participants will maintain their habitual diet.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female and male participants
* Age range 18 - 50
* BMI range \>20 kg/m2 at screening visit
* Regular eating pattern (3 meals per day on at least 5 days per week)
* Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* Stable body weight for the last 6 months

Exclusion Criteria

* Currently smoking or willingness to smoke during the study period
* Pregnancy, lactation or wish to become pregnant during the study period
* 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
* Allergy/intolerance to milk, egg, nuts, soy or sesame
* Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* 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

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Verbeke

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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KU Leuven

Leuven, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Georgia Chatonidi

Role: CONTACT

+3216194324

Facility Contacts

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Georgia Chatonidi

Role: primary

+32 16 19 43 24

Kristin Verbeke

Role: backup

+32 16 33 01 50

Other Identifiers

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S66499

Identifier Type: -

Identifier Source: org_study_id

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