Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Tonalin SG1000T FFA

Study type: Interventional

Funder types: Other

Identifiers

NCT01099163

2387

Details and patient eligibility

About

Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes mellitus > 5 years
• HbA1c ≤ 9%
• Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2)
• Age ≥ 30 and ≤ 70 years (postmenopausal if female)
• Stable medical therapy for past 3 months
• Stable serum glucose for past 3 months (128-180 mg/Dl)
• Age between 30 to 50
• Use of metformin
• TG < 240 mg/Dl
• No alcohol, no insulin, no smoke
• No pregnancy, no menopause

Exclusion criteria

• Personal history of coronary heart disease
• Cerebrovascular disease or vascular disease
• Renal or hepatic disease
• Inflammatory diseases and thyroid diseases within the last years
• Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

3g CLA

Experimental group

Description:

3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E

Treatment:

Dietary Supplement: Tonalin SG1000T FFA

3 g CLA

Active Comparator group

Description:

3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo

Treatment:

Dietary Supplement: Tonalin SG1000T FFA

3 g MCT + vit E placebo

No Intervention group

Description:

3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo