Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents

NACompletedINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

January 31, 2017

Conditions
ObesityInsulin Resistance
Interventions
DIETARY_SUPPLEMENT

Omega3 and an hypocaloric diet.

Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.

DIETARY_SUPPLEMENT

Sunflower oil with an hypocaloric diet.

Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.

Trial Locations (1)

06720

"Unit or research in Medical Nutrition, Pediatric Hospital CMN Siglo XXI, Instituto Mexicano del Seguro Social", Mexico City

All Listed Sponsors
lead

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

NCT01456221 - Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents | Biotech Hunter | Biotech Hunter