Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women’s Diabetes Study)
Overview
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).
Full Title of Study: “Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women’s Diabetes Study)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: November 2006
Detailed Description
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.
Interventions
- Dietary Supplement: Conjugated Linoleic Acid (CLA)
- 6.4 g CLA/day, capsule form, for 16 week arms
- Dietary Supplement: Safflower OIl
- 8.0g/day safflower oil
Arms, Groups and Cohorts
- Placebo Comparator: Safflower Oil
- 8.0 g/day safflower oil
- Experimental: CLA 6.4g/day
- Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil
Clinical Trial Outcome Measures
Primary Measures
- change in plasma glucose AUC
- Time Frame: baseline and week 16
- significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
Secondary Measures
- change in insulin sensitivity
- Time Frame: baseline and every 4 weeks until week 16
- change in glucose tolerance
- Time Frame: baseline and every 4 weeks for 16 weeks
- change in HbA1c
- Time Frame: baseline and week 16
- change in blood lipid profile
- Time Frame: baseline and every 4 weeks for 16 weeks
- change in serum adipocytokines
- Time Frame: baseline and every 4 weeks for 16 weeks
- change in hepatic enzymes
- Time Frame: baseline and every 4 weeks for 16 weeks
- change in body composition
- Time Frame: baseline and every 4 weeks for 16 weeks
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Ohio State University
- Collaborator
- Cognis
- Provider of Information About this Clinical Study
- Martha A. Belury, The Ohio State University
- Overall Official(s)
- Martha A. Belury, PhD, Principal Investigator, Ohio State University
Citations Reporting on Results
Norris LE, Collene AL, Asp ML, Hsu JC, Liu LF, Richardson JR, Li D, Bell D, Osei K, Jackson RD, Belury MA. Comparison of dietary conjugated linoleic acid with safflower oil on body composition in obese postmenopausal women with type 2 diabetes mellitus. Am J Clin Nutr. 2009 Sep;90(3):468-76. doi: 10.3945/ajcn.2008.27371. Epub 2009 Jun 17.
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