Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 Diabetes

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

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

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The purpose of this study is to determine whether the addition of Salvia hispanica L. Alba (Salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.

Detailed Description

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Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes.

Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Salba diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C \< 9.0%) on oral hypoglycemic agents or diet only were asked to participate.

Exclusion Criteria

* Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with BMI\>38 kg/m2, smoking or significant alcohol intake (\>2 drinks/day), serum TG \>4.0 mmol/L, and those with complications of diabetes were excluded. Subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. Subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume \>50% of supplements provided, had a significant weight change (defined as \>2.5 kg), or if their level of physical activity did not remain constant over the course of the study.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.

Reference Type DERIVED

PMID: 17686832 (View on PubMed)

Other Identifiers

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01-062

Identifier Type: -

Identifier Source: org_study_id