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

Obesity Clinical Trial

— CLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503047
• Other study ID #: HULP-2297
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2011
• Last updated: January 2, 2012
• Start date: March 2008

Study information

• Verified date: January 2012
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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
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)

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body composition(DXA)		0, 3, 6 months	No
Secondary	anthropometric parameters	paramteres measured were: Weight, Height and Waist Circunference.	0,1, 2, 3, 4, 5 and 6 month	No
Secondary	Biochemical parameters	lipid profile glucose, insulin CR-P PAI-1 adiponectin, leptin creatinine GPT and GOT transaminases	0, 3 and 6 month	Yes
Secondary	HOMA-Index	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	Yes

External Links

•   institution web