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

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Status and phase: Completed; Phase 4

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Tonalin®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01503047

HULP-2297

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

CLA group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Tonalin®

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo