Conjugated Linoleic Acid (1:1 Isomer Mixture) Intake in Overweight People
Phase 4
Completed
- Conditions
- OverweightObesity
- Interventions
- Dietary Supplement: Tonalin®Dietary Supplement: Placebo
- Registration Number
- NCT01503047
- 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
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
- Arm && Interventions
Group Intervention Description CLA group 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 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, P group.
- 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