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OpenTrials
Completed

NCT Number: NCT00362011

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

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.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital

Toronto, Ontario, M5C2T2, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salba diet

Behavioral

Primary outcomes

  1. Hemoglobin A1c

Secondary outcomes

  1. Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)

  2. safety (liver, kidney and haemostatic function)

  3. compliance (plasma fatty-acids, returned supplements, diet records, body weight).

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2001
First posted
Aug 9, 2006
Registry last updated
Aug 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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