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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

ClinicalTrials.gov Identifier:

NCT01503047

First received: December 30, 2011

Last updated: January 2, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 30, 2011
Last Updated Date	January 2, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 30, 2011)	body composition(DXA) [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01503047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 30, 2011)	anthropometric parameters [ Time Frame: 0,1, 2, 3, 4, 5 and 6 month ] [ Designated as safety issue: No ] paramteres measured were: Weight, Height and Waist Circunference. Biochemical parameters [ Time Frame: 0, 3 and 6 month ] [ Designated as safety issue: Yes ] lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases HOMA-Index [ Time Frame: 0, 3, 6 month ] [ Designated as safety issue: Yes ] insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People
Official Title ^ICMJE	Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tonalin(R)Intake in Overweight People
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Overweight Obesity
Intervention ^ICMJE	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) 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)
Study Arm (s)	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) Intervention: Dietary Supplement: Tonalin® 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. Intervention: Dietary Supplement: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	Not Provided
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01503047
Other Study ID Numbers ^ICMJE	HULP-2297
Has Data Monitoring Committee	Not Provided
Responsible Party	Ignacio Galicia, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Study Sponsor ^ICMJE	Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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