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

Catholic University (KU) of Leuven

Status: Enrolling

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

Treatments: Other: Dietary Intervention with Brown Bread; Other: Dietary Intervention with Sourdough Bread

Study type: Interventional

Funder types: Other

Identifiers

NCT05590611

S66499

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Brown Bread

Placebo Comparator group

Treatment:

Other: Dietary Intervention with Brown Bread

Wholemeal Sourdough Bread

Active Comparator group

Treatment:

Other: Dietary Intervention with Sourdough Bread