NCT00362011

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
Last Updated

August 9, 2006

Status Verified

February 1, 2001

First QC Date

August 8, 2006

Last Update Submit

August 8, 2006

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

Secondary Outcomes (3)

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

  • safety (liver, kidney and haemostatic function)

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

Interventions

Salba dietBEHAVIORAL

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C2T2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 17686832DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

March 1, 2001

Last Updated

August 9, 2006

Record last verified: 2001-02

Locations

CA(1)