Barley Tortillas Study in Healthy Volunteers

NCT ID: NCT00831285

Last Updated: 2010-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-02-28

Brief Summary

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The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.

Detailed Description

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Specifically, we wish to examine the glycemic response of barley tortillas containing different ratios of amylose and amylopectin and different amounts of soluble and insoluble fibre with an appropriate control during acute phase testing in healthy volunteers. Possible relationships between composition of the barley tortillas and the degree of physiological response will also be investigated as the secondary objective.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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tortilla with high amylose flour

Group Type EXPERIMENTAL

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

barley tortilla with low amylose flour

Group Type EXPERIMENTAL

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

barley tortilla with low amylose flour and soluble fibre

Group Type EXPERIMENTAL

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

barley tortilla with low amylose flour and insoluble fibre

Group Type EXPERIMENTAL

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

glucose

Group Type ACTIVE_COMPARATOR

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

barley tortilla with low amylose flour and low soluble fibre

Group Type EXPERIMENTAL

food product

Intervention Type DIETARY_SUPPLEMENT

food product given at one of six visits

Interventions

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food product

food product given at one of six visits

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Department of Human Nutritional Science, University of Manitoba

Principal Investigators

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Carla Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17151593 (View on PubMed)

Related Links

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http://www.sbrc.ca/ccarm

Canadian Centre for AgriFood Research in Health and Medicine

Other Identifiers

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Agriculture and Agri-food CAN

Identifier Type: -

Identifier Source: secondary_id

B2008:133

Identifier Type: -

Identifier Source: org_study_id

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