Barley Tortillas Study in Healthy Volunteers
A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers
2 other identifiers
interventional
12
1 country
1
Brief Summary
The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Dec 2008
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFebruary 22, 2010
February 1, 2010
1.2 years
January 26, 2009
February 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calculation of area under the curve for glucose and insulin
6 weeks
Secondary Outcomes (2)
comparison of food groups using ANOVA
6 weeks
measurement of incretins
6 weeks
Study Arms (6)
tortilla with high amylose flour
EXPERIMENTALbarley tortilla with low amylose flour
EXPERIMENTALbarley tortilla with low amylose flour and soluble fibre
EXPERIMENTALbarley tortilla with low amylose flour and insoluble fibre
EXPERIMENTALglucose
ACTIVE COMPARATORbarley tortilla with low amylose flour and low soluble fibre
EXPERIMENTALInterventions
food product given at one of six visits
Eligibility Criteria
You may qualify if:
- male or female age 18 to 40 years
- normal glycated hemoglobin of \<6%
- BMI of 20 to 30
- must read the consent form
- must comply with the protocol requirements
You may not qualify if:
- allergies to barley flour
- presence of chronic conditions such as cardiovascular disease, hypertension, disorders affecting the gastrointestinal tract, thyroid disease, and requiring medication for these conditions
- requiring medication for glycemic control
- consumption of supplements which have an effect on blood glucose response
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, R2H 2A6, Canada
Related Publications (1)
Makelainen H, Anttila H, Sihvonen J, Hietanen RM, Tahvonen R, Salminen E, Mikola M, Sontag-Strohm T. The effect of beta-glucan on the glycemic and insulin index. Eur J Clin Nutr. 2007 Jun;61(6):779-85. doi: 10.1038/sj.ejcn.1602561. Epub 2006 Dec 6.
PMID: 17151593BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Taylor, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 28, 2009
Study Start
December 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 22, 2010
Record last verified: 2010-02