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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
6.4 g CLA/day, capsule form, for 16 week arms
8.0g/day safflower oil
The Ohio State University
Columbus, Ohio, United States
change in plasma glucose AUC
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
Time frame: baseline and week 16
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
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