Barley Bread and Metabolic Disease
Barleybread
Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedAugust 15, 2016
August 1, 2016
7 months
July 19, 2016
August 10, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Mineral status
8-9 weeks
Study Arms (2)
Barley bread
ACTIVE COMPARATORTwo loaves, 2 x 120 g loaf/day for 3 weeks.
Wheat bread
ACTIVE COMPARATORTwo loaves, 2 x 120 g loaf/day for 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 19, 2016
First Posted
August 15, 2016
Study Start
September 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
August 15, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share