Bread Replacement - Facing the Challenge to Improve Its Quality for Better Metabolic Health
1 other identifier
interventional
155
1 country
1
Brief Summary
This is a multicenter study testing the effect of bread containing beta-glucan on glycemic control in participants with intermediate hyperglycemia. The main hypothesis of the study is that bread enriched with beta-glucan will have a positive effect on blood glucose control (HbA1c) in persons with intermediate hyperglycemia. Bread (intervention and control) will be produced by Nofima (Ås, Norway) using food-grade beta-glucan from oat and barley and shipped to the study centers (Bergen (N), Gothenburg (S), Paderborn, and Leipzig (D)) and there distributed for free to the participants of the study. The study will last for 16 weeks with measurements at baseline, after 8 weeks and after 16 weeks. Blood and urine samples will be taken, anthropometry and body composition measured, and questionnaires on health status and socio-economic status, physical activity, nicotine use, alcohol habits, chronotype, quality of life, and consumer acceptance of the study bread will be filled in.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2021
CompletedFirst Submitted
Initial submission to the registry
July 7, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedDecember 4, 2023
December 1, 2023
2.4 years
July 7, 2021
December 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic control
Measurement of HbA1c
16 weeks
Secondary Outcomes (8)
fasting capillary blood glucose
16 weeks
Body weight
16 weeks
Lipids
16 weeks
Consumer acceptance
8 weeks
Liver enzymes
16 weeks
- +3 more secondary outcomes
Study Arms (2)
Beta-glucan bread
EXPERIMENTALFrozen bread is administered to the participants for home storage. Bread is thawed at home before consumption. Dosage: At least 3 slices of bread 6 days per week for 16 weeks
Control bread
PLACEBO COMPARATORFrozen bread is administered to the participants for home storage. Bread is thawed at home before consumption. Dosage: At least 3 slices of bread 6 days per week for 16 weeks
Interventions
Frozen bread is administered to the participants for home storage. Bread is thawed at home before consumption. Dosage: At least 3 slices of bread 6 days per week for 16 weeks
Eligibility Criteria
You may qualify if:
- HbA1c 35-50 mmol/mol
- BMI ≥ 27 m2/kg
- regular bread eaters
- freezing capacity of at least 2 bread
You may not qualify if:
- chronic diseases like T2DM, CVD, cancer (within the last three years)
- unknown or untreated hypertension \>160/100 mmHg
- celiac diseases, intolerance, or allergies for nuts, milk, eggs, wheat, mustard, seeds
- use of anti-diabetic drugs
- pregnancy and breastfeeding
- patients planned to have or had a bariatric surgery
- alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Paderborn Universitycollaborator
- University of Leipzigcollaborator
- Chalmers University of Technologycollaborator
- Nofimacollaborator
Study Sites (1)
University of Bergen
Bergen, 5021, Norway
Related Publications (2)
Hjorth T, Schadow A, Revheim I, Spielau U, Meyer K, Rieder A, Varela P, Ballance S, Koerner A, Landberg R, Buyken AE, Dierkes J, Rosendahl-Riise H. Effectiveness of regular oat beta-glucan-enriched bread compared with whole-grain wheat bread on long-term glycemic control in adults at risk of type 2 diabetes: a randomized controlled trial. Am J Clin Nutr. 2025 Sep;122(3):724-732. doi: 10.1016/j.ajcnut.2025.06.018. Epub 2025 Jun 24.
PMID: 40571100DERIVEDHjorth T, Schadow A, Revheim I, Spielau U, Thomassen LM, Meyer K, Piotrowski K, Rosendahl-Riise H, Rieder A, Varela P, Lysne V, Ballance S, Koerner A, Landberg R, Buyken A, Dierkes J. Sixteen-week multicentre randomised controlled trial to study the effect of the consumption of an oat beta-glucan-enriched bread versus a whole-grain wheat bread on glycaemic control among persons with pre-diabetes: a study protocol of the CarbHealth study. BMJ Open. 2022 Aug 23;12(8):e062066. doi: 10.1136/bmjopen-2022-062066.
PMID: 35998955DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jutta Dierkes, PhD
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2021
First Posted
August 6, 2021
Study Start
May 7, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
December 4, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share