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Barley Bread and Metabolic Disease (Barleybread)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02867215
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Barley bread Other: Wheat bread Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. LDL-c levels evaluated by analysis of fasting blood samples [ Time Frame: 8-9 weeks ]
    Evaluated by analysis of fasting blood samples

  2. Glucose levels evaluated by analysis of fasting blood samples [ Time Frame: 8-9 weeks ]
    Evaluated by analysis of fasting blood samples

  3. Insulin levels evaluated by analysis of fasting blood samples [ Time Frame: 8-9 weeks ]
    Evaluated by analysis of fasting blood samples

Secondary Outcome Measures :
  1. Mineral status [ Time Frame: 8-9 weeks ]
    Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: Arne Astrup, Professor, University of Copenhagen Identifier: NCT02867215    
Other Study ID Numbers: H-15010303
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Metabolic Syndrome
Metabolic Diseases
Insulin Resistance
Glucose Metabolism Disorders