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Bread Replacement - Facing the Challenge to Improve Its Quality for Better Metabolic Health

NCT04994327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Beta-glucan bread

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

Sponsors & Collaborators

  • Paderborn University

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • Chalmers University of Technology

    collaborator OTHER

  • Nofima

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Jutta Dierkes, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994327 on ClinicalTrials.gov