Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People

Phase 4

Completed

• Conditions: Overweight; Obesity

• Registration Number: NCT01503047
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Brief Summary

The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) on weight control and body composition in healthy overweight individuals who maintained their normal dietary and exercise patterns.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-03
• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2011-12-30
• Status Verified: 2012-01
• Study First Posted: 2012-01-02
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• aged 30-55 years
• grade II overweight (BMI≥27 but <30 kg/m2)
• not to be adhered to any calorie restriction diet
• not to be taking any weight control medication or have lost more than 5 kg in the three months prior to the study

Exclusion Criteria

• suffering of serious concomitant disease such as diabetes mellitus type II, metabolic syndrome (according to the criteria of the Adult Treatment Panel III), cancer, kidney disease, HIV, tuberculosis, cardiovascular disease, chronic obstructive pulmonary disease, eating disorders.
• having undergone bariatric surgery and/or intestinal resection
• breastfeeding and pregnancy.
• not to give their signed, informed consent to be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
body composition(DXA)	0, 3, 6 months

Secondary Outcome Measures

Name	Time	Method
anthropometric parameters	0,1, 2, 3, 4, 5 and 6 month	paramteres measured were: Weight, Height and Waist Circunference.
Biochemical parameters	0, 3 and 6 month	lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases
HOMA-Index	0, 3, 6 month	insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain