NCT05590611RecruitingNot Applicable
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- KU Leuven
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Energy intake (kilocalories)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Brown Bread
Placebo Comparator
Intervention: Dietary Intervention with Brown Bread (Other)
Wholemeal Sourdough Bread
Active Comparator
Intervention: Dietary Intervention with Sourdough Bread (Other)
Outcomes
Primary Outcomes
Energy intake (kilocalories)
Time Frame: 4 weeks
Assessed via 4-day food diaries using a mobile app
Secondary Outcomes
- Body weight(4 weeks)
- Blood lipid levels(4 weeks)
Investigators
Kristin Verbeke
Full professor
KU Leuven
Study Sites (1)
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