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

Overweight and Obesity Clinical Trial

— SOBER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590611
• Other study ID #: S66499
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: KU Leuven
• Contact: Georgia Chatonidi
• Phone: +3216194324
• Email: georgia.chatonidi[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 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 >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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake (kilocalories)	Assessed via 4-day food diaries using a mobile app	4 weeks
Secondary	Body weight		4 weeks
Secondary	Blood lipid levels	Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically	4 weeks