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

Sponsor

KU Leuven (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05590611

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Appetite Regulation Energy Intake Body Weight Changes Eating Behavior Overweight and Obesity	Other: Dietary Intervention with Brown Bread Other: Dietary Intervention with Sourdough Bread	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Brown Bread	Other: 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.
Active Comparator: Wholemeal Sourdough Bread	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.

Arm

Intervention/Treatment

Placebo Comparator: Brown Bread

Other: 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.

Active Comparator: Wholemeal Sourdough Bread

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.

Outcome Measures

Primary Outcome Measures

Energy intake (kilocalories) [4 weeks]
Assessed via 4-day food diaries using a mobile app

Secondary Outcome Measures

Body weight [4 weeks]
Blood lipid levels [4 weeks]
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven	Vlaams Brabant	Belgium	3000

Sponsors and Collaborators

KU Leuven

Investigators

Principal Investigator: Kristin Verbeke, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristin Verbeke, Full professor, KU Leuven

ClinicalTrials.gov Identifier:

NCT05590611

Other Study ID Numbers:

S66499

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 21, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Body Weight

Body Weight Changes

Study Results

No Results Posted as of Oct 21, 2022