Barley Bread and Metabolic Disease (Barleybread)

Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Barley bread; Other: Wheat bread

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 53 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Barley bread; Two loaves, 2 x 120 g loaf/day for 3 weeks.	Other: Barley bread; 120g barley bread per day for 3 weeks.
ACTIVE_COMPARATOR: Wheat bread; Two loaves, 2 x 120 g loaf/day for 3 weeks.	Other: Wheat bread; 120g wheat bread per day for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-c levels evaluated by analysis of fasting blood samples	Evaluated by analysis of fasting blood samples	8-9 weeks
Glucose levels evaluated by analysis of fasting blood samples	Evaluated by analysis of fasting blood samples	8-9 weeks
Insulin levels evaluated by analysis of fasting blood samples	Evaluated by analysis of fasting blood samples	8-9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mineral status	Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry	8-9 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (ESTIMATE): August 15, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Metabolic Diseases
• Other Study ID Numbers: H-15010303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES