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

January 2, 2012 updated by: Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLA group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
Dietary supplement: Tonalin®
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
Placebo Comparator: Placebo group
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo, P group.
Dietary supplement: Placebo
Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body composition(DXA)
Time Frame: 0, 3, 6 months
0, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometric parameters
Time Frame: 0,1, 2, 3, 4, 5 and 6 month
paramteres measured were: Weight, Height and Waist Circunference.
0,1, 2, 3, 4, 5 and 6 month
Biochemical parameters
Time Frame: 0, 3 and 6 month
lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases
0, 3 and 6 month
HOMA-Index
Time Frame: 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.
0, 3, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP-2297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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