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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Dietary Intervention with Brown Bread
* Other: Dietary Intervention with Sourdough Bread


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Brown Bread<br> | Other: Dietary Intervention with Brown Bread<br>* 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.<br>|
| Active Comparator: Wholemeal Sourdough Bread<br> | Other: Dietary Intervention with Sourdough Bread<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake (kilocalories) | Assessed via 4-day food diaries using a mobile app | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 4 weeks | 
| Blood lipid levels | Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically | 4 weeks |