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

Primary Purpose

Appetite Regulation, Energy Intake, Body Weight Changes

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Dietary Intervention with Brown Bread

Dietary Intervention with Sourdough Bread

About this trial

This is an interventional prevention trial for Appetite Regulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Female and male participants
Age range 18 - 50
BMI range27 - 32 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)

Sites / Locations

KU LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Brown Bread

Wholemeal Sourdough Bread

Arm Description

Outcomes

Primary Outcome Measures

Energy intake (kilocalories)

Assessed via 4-day food diaries using a mobile app

Secondary Outcome Measures

Body weight

Blood lipid levels

Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

Full Information

NCT ID

NCT05590611

First Posted

October 17, 2022

Last Updated

June 2, 2023

Sponsor

KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT05590611

Brief Title

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

Acronym

SOBER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Brown Bread

Arm Type

Placebo Comparator

Arm Title

Wholemeal Sourdough Bread

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Dietary Intervention with Brown Bread

Intervention Description

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

Intervention Name(s)

Dietary Intervention with Sourdough Bread

Intervention Description

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.

Primary Outcome Measure Information:

Title

Energy intake (kilocalories)

Description

Assessed via 4-day food diaries using a mobile app

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Body weight

Time Frame

4 weeks

Title

Blood lipid levels

Description

Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Georgia Chatonidi

Phone

+3216194324

georgia.chatonidi@kuleuven.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin Verbeke

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

KU Leuven

City

Leuven

State/Province

Vlaams Brabant

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georgia Chatonidi

Phone

+32 16 19 43 24

georgia.chatonidi@kuleuven.be

First Name & Middle Initial & Last Name & Degree

Kristin Verbeke

Phone

+32 16 33 01 50

kristin.verbeke@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No IPD will be shared with other researchers.

Learn more about this trial

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

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