Obesity, Overweight
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTonalin®
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_SUPPLEMENTPlacebo
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)
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body composition(DXA) | 0, 3, 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed