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Barley Bread and Metabolic Disease (Barleybread)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Barley bread
Wheat bread
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

20 Years - 53 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Barley bread

    Wheat bread

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    LDL-c levels evaluated by analysis of fasting blood samples
    Evaluated by analysis of fasting blood samples
    Glucose levels evaluated by analysis of fasting blood samples
    Evaluated by analysis of fasting blood samples
    Insulin levels evaluated by analysis of fasting blood samples
    Evaluated by analysis of fasting blood samples

    Secondary Outcome Measures

    Mineral status
    Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry

    Full Information

    First Posted
    July 19, 2016
    Last Updated
    August 10, 2016
    Sponsor
    University of Copenhagen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02867215
    Brief Title
    Barley Bread and Metabolic Disease
    Acronym
    Barleybread
    Official Title
    Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Copenhagen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Barley bread
    Arm Type
    Active Comparator
    Arm Description
    Two loaves, 2 x 120 g loaf/day for 3 weeks.
    Arm Title
    Wheat bread
    Arm Type
    Active Comparator
    Arm Description
    Two loaves, 2 x 120 g loaf/day for 3 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Barley bread
    Intervention Description
    120g barley bread per day for 3 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Wheat bread
    Intervention Description
    120g wheat bread per day for 3 weeks.
    Primary Outcome Measure Information:
    Title
    LDL-c levels evaluated by analysis of fasting blood samples
    Description
    Evaluated by analysis of fasting blood samples
    Time Frame
    8-9 weeks
    Title
    Glucose levels evaluated by analysis of fasting blood samples
    Description
    Evaluated by analysis of fasting blood samples
    Time Frame
    8-9 weeks
    Title
    Insulin levels evaluated by analysis of fasting blood samples
    Description
    Evaluated by analysis of fasting blood samples
    Time Frame
    8-9 weeks
    Secondary Outcome Measure Information:
    Title
    Mineral status
    Description
    Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry
    Time Frame
    8-9 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    53 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Barley Bread and Metabolic Disease

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