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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3g CLA | Experimental | 3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E |
|
| 3 g CLA | Active Comparator | 3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo |
|
| 3 g MCT + vit E placebo | No Intervention | 3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonalin SG1000T FFA | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| insulin sensitivity | ||
| beta cell function | ||
| glycosylated hemoglobin |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin) | ||
| systolic and diastolic blood pressure | ||
| serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taleghani Hospital | Tehran | Tehran Province | 1981619573 | Iran |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| fibrinogen, PAI-1 |
| body fat using bioimpedance |
| oxidative stress (MDA) |