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

NCT05590611 | Unknown

• 1 other identifier: S66499
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Energy intake (kilocalories)

  Assessed via 4-day food diaries using a mobile app

  4 weeks

Secondary Outcomes (2)

• Body weight

  4 weeks

• Blood lipid levels

  4 weeks

Study Arms (2)

Brown Bread

PLACEBO COMPARATOR

Other: Dietary Intervention with Brown Bread

Wholemeal Sourdough Bread

ACTIVE COMPARATOR

Other: Dietary Intervention with Sourdough Bread

Interventions

Dietary Intervention with Brown Bread OTHER

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.

Brown Bread

Dietary Intervention with Sourdough Bread OTHER

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.

Wholemeal Sourdough Bread

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Body Weight Changes; Feeding Behavior; Overweight; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Kristin Verbeke

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Chatonidi

CONTACT

+3216194324; georgia.chatonidi@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)