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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362011
• Other study ID #: 01-062
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2006
• Last updated: August 8, 2006
• Start date: March 2001

Study information

• Verified date: February 2001
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Salba diet

Locations

Country	Name	City	State
Canada	St. Michael’s Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c
Secondary	Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)
Secondary	safety (liver, kidney and haemostatic function)
Secondary	compliance (plasma fatty-acids, returned supplements, diet records, body weight).