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
About this trial
This is an interventional prevention trial for Metabolic Syndrome
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
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
NCT ID
NCT02867215
First Posted
July 19, 2016
Last Updated
August 10, 2016
Sponsor
University of Copenhagen
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
Learn more about this trial
Barley Bread and Metabolic Disease
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