NCT04994327

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

Completed NA Last updated 4 December 2023

What this trial tests

NA trial testing Beta-glucan bread in Bread in 155 participants. Completed in 30 September 2023.

Timeline

7 May 2021

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	University of Bergen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	155
Start date	7 May 2021
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across Norway

Drugs / interventions tested

• Beta-glucan bread

Conditions studied

• Bread — all drugs for Bread →
• Hyperglycemia — all drugs for Hyperglycemia →
• Glycemic Control — all drugs for Glycemic Control →
• PreDiabetes — all drugs for PreDiabetes →

Sponsor

University of Bergen

Who can join

Adults 40 to 70, any sex, with Bread or Hyperglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Hjorth T, Schadow A, Revheim I, Spielau U, et al · · 2022 · cited 3× · PMID 35998955 · DOI 10.1136/bmjopen-2022-062066
2. Effectiveness of regular oat β-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.
   Hjorth T, Schadow A, Revheim I, Spielau U, et al · · 2025 · cited 1× · PMID 40571100 · DOI 10.1016/j.ajcnut.2025.06.018