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

NCT01099163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Tonalin SG1000T FFA

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-10-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099163 on ClinicalTrials.gov