Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

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

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).

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Detailed Description

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The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Safflower Oil

8.0 g/day safflower oil

Group Type PLACEBO_COMPARATOR

Safflower OIl

Intervention Type DIETARY_SUPPLEMENT

8.0g/day safflower oil

CLA 6.4g/day

Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil

Group Type EXPERIMENTAL

Conjugated Linoleic Acid (CLA)

Intervention Type DIETARY_SUPPLEMENT

6.4 g CLA/day, capsule form, for 16 week arms

Interventions

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Conjugated Linoleic Acid (CLA)

6.4 g CLA/day, capsule form, for 16 week arms

Intervention Type DIETARY_SUPPLEMENT

Safflower OIl

8.0g/day safflower oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Type 2 diabetes mellitus
* obese
* postmenopausal
* HbA1c \>6.49 and \<14.1

Exclusion Criteria

* use of tobacco
* substance abuse
* impaired cognitive function
* renal disease
* abnormal liver function
* gastrointestinal diseases
* use of exogenous insulin
* use of hormone replacement therapy currently or within past 6 months
* pacemaker/defibrillator

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No