HealthyNCT00831285
Barley Tortillas Study in Healthy Volunteers
A study testing food product in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial summary
The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- food product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers
The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.
Read the detailed description
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
- Healthy
- Being tested
- food product
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food productDietary supplement
food product given at one of six visits
| Study group | Role | What they receive |
|---|---|---|
| tortilla with high amylose flour | Experimental | Not described Receives: Dietary Supplement: food product |
| barley tortilla with low amylose flour | Experimental | Not described Receives: Dietary Supplement: food product |
| barley tortilla with low amylose flour and soluble fibre | Experimental | Not described Receives: Dietary Supplement: food product |
| barley tortilla with low amylose flour and insoluble fibre | Experimental | Not described Receives: Dietary Supplement: food product |
| glucose | Active comparator | Not described Receives: Dietary Supplement: food product |
| barley tortilla with low amylose flour and low soluble fibre | Experimental | Not described Receives: Dietary Supplement: food product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of area under the curve for glucose and insulin
Measured: 6 weeks
Secondary outcomes (2)
comparison of food groups using ANOVA
Measured: 6 weeks
measurement of incretins
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831285
- Sponsor's protocol ID
- B2008:133
- Other IDs
- Agriculture and Agri-food CAN
- Status last verified
- Feb 2010
- First submitted
- 26 Jan 2009
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17151593
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00831285
- Acronym / sponsor ID
- B2008:133
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tortilla with high amylose flour | Experimental | Dietary Supplement: food product |
| barley tortilla with low amylose flour | Experimental | Dietary Supplement: food product |
| barley tortilla with low amylose flour and soluble fibre | Experimental | Dietary Supplement: food product |
| barley tortilla with low amylose flour and insoluble fibre | Experimental | Dietary Supplement: food product |
| glucose | Active comparator | Dietary Supplement: food product |
| barley tortilla with low amylose flour and low soluble fibre | Experimental | Dietary Supplement: food product |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food productfood product given at one of six visits | Dietary supplement | barley tortilla with low amylose flour, barley tortilla with low amylose flour and insoluble fibre, barley tortilla with low amylose flour and low soluble fibre, barley tortilla with low amylose flour and soluble fibre, glucose, tortilla with high amylose flour |
Primary outcome
Calculation of area under the curve for glucose and insulin
Time frame: 6 weeks
2 secondary outcomes
comparison of food groups using ANOVA
Time frame: 6 weeks
measurement of incretins
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2010.
- Background: PubMed 17151593Makelainen 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.
- Canadian Centre for AgriFood Research in Health and MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Taylor, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food product in people with Healthy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of area under the curve for glucose and insulin (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00831285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2010.