Barley Bread and Metabolic Disease

NCT ID: NCT02867215

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-04-30

Brief Summary

The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.

Detailed Description

Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.

The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.

The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Barley bread

Two loaves, 2 x 120 g loaf/day for 3 weeks.

Group Type: ACTIVE_COMPARATOR

Barley bread

Intervention Type: OTHER

120g barley bread per day for 3 weeks.

Wheat bread

Two loaves, 2 x 120 g loaf/day for 3 weeks.

Group Type: ACTIVE_COMPARATOR

Wheat bread

Intervention Type: OTHER

120g wheat bread per day for 3 weeks.

Interventions

Barley bread

120g barley bread per day for 3 weeks.

Intervention Type: OTHER

Wheat bread

120g wheat bread per day for 3 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Like and tolerate wheat/ barley bread products.
• Age: 20 - 53 years
• Body mass index (BMI): 23 - 30 kg/m2
• Weight stable (<3 kg weight change during the last 6 months)
• Apparently healthy
• Informed consent signed
• Freezer capacity for 1 week bread provision
• Can attend all visits required for the study

Exclusion Criteria

• Wheat/gluten or barley intolerance
• Smoking on a daily basis
• Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
• Diagnosed with any form of diabetes or cardiovascular disease
• Reported chronic gastrointestinal disorders
• Taking dietary supplements during or one month prior to the study
• Lack of cooperation and adherence to the protocol
• Use of prescription medication will be evaluated on an individual basis
• Blood donation within 3 months prior to study start or during the study
• Participation in other clinical trials

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Arne Astrup

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

H-15010303

Identifier Type: -

Identifier Source: org_study_id