Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
Primary Purpose
Appetite Regulation, Energy Intake, Body Weight Changes
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dietary Intervention with Brown Bread
Dietary Intervention with Sourdough Bread
Sponsored by
About this trial
This is an interventional prevention trial for Appetite Regulation
Eligibility Criteria
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)
Sites / Locations
- KU LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Brown Bread
Wholemeal Sourdough Bread
Arm Description
Outcomes
Primary Outcome Measures
Energy intake (kilocalories)
Assessed via 4-day food diaries using a mobile app
Secondary Outcome Measures
Body weight
Blood lipid levels
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05590611
Brief Title
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility
Acronym
SOBER
Official Title
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility (SOBER)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Regulation, Energy Intake, Body Weight Changes, Eating Behavior, Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brown Bread
Arm Type
Placebo Comparator
Arm Title
Wholemeal Sourdough Bread
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dietary Intervention with Brown Bread
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention with Sourdough Bread
Intervention Description
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.
Primary Outcome Measure Information:
Title
Energy intake (kilocalories)
Description
Assessed via 4-day food diaries using a mobile app
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Body weight
Time Frame
4 weeks
Title
Blood lipid levels
Description
Plasma total cholesterol, triglycerides, LDL and HDL cholesterol, colourimetrically
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Chatonidi
Phone
+3216194324
Email
georgia.chatonidi@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Verbeke
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Chatonidi
Phone
+32 16 19 43 24
Email
georgia.chatonidi@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Kristin Verbeke
Phone
+32 16 33 01 50
Email
kristin.verbeke@kuleuven.be
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers.
Learn more about this trial
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility
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