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

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

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 Overview

• Status: Recruiting
• Conditions: Body Weight Changes; Overweight and Obesity; Eating Behavior; Appetite Regulation; Energy Intake
• Intervention / Treatment: Other: Dietary Intervention with Brown Bread; Other: Dietary Intervention with Sourdough Bread

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Chatonidi; Phone Number: +3216194324; Email: georgia.chatonidi@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • KU Leuven
      • Contact: Georgia Chatonidi; Phone Number: +32 16 19 43 24; Email: georgia.chatonidi@kuleuven.be
      • Contact: Kristin Verbeke; Phone Number: +32 16 33 01 50; Email: kristin.verbeke@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Brown Bread	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.
Active Comparator: Wholemeal Sourdough Bread	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Kristin Verbeke, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes
• Other Study ID Numbers: S66499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No