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

NCT01456221 | Completed Results DMC

• 1 other identifier: R-2011-785-037
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if a supplement containing omega-3 long chain polyunsaturated fatty acids for three months reduce obesity and insulin resistance to obese adolescents if administered together with a hypocaloric diet.

Conditions

Obesity; Insulin Resistance

Keywords

Obesity; Insulin resistance; Omega3 long chain polyunsaturated fatty acids

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance

  Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through Homeostasis Model Assessment Index (HOMA), calculated by formula: (glucose, mg \* insulin,µU)/405. Where HOMA\>3.16 indicated insulin resistance index.

  At baseline (at diagnosis), three months, throughout six months.

Secondary Outcomes (1)

• Nutritional Status

  At baseline (at diagnosis), three months, throughout six months.

Other Outcomes (2)

• Change in Insulin Resistance Through Fasting Insulin

  At baseline (at diagnosis), three months, throughout six months.

• Nutritional Status Through Waist Circumference

  At baseline (at diagnosis), three months, throughout six months.

Study Arms (2)

omega 3 and an hypocaloric diet

EXPERIMENTAL

Participants will receive a supplement containing omega 3: Docosahexaenoic acid (DHA) and EPA fatty acids together with an hypocaloric diet.

Dietary Supplement: Omega3 and an hypocaloric diet.

Placebo

PLACEBO COMPARATOR

Participants will receive a supplement containing sunflower oil with an hypocaloric diet.

Dietary Supplement: Sunflower oil with an hypocaloric diet.

Interventions

Omega3 and an hypocaloric diet. DIETARY_SUPPLEMENT

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.

Also known as: DHA and EPA fatty acids, Docosahexaenoic fatty acid, Eicosapentaenoic fatty acid, ®MaxEpa, Merck Laboratory

omega 3 and an hypocaloric diet

Sunflower oil with an hypocaloric diet. DIETARY_SUPPLEMENT

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.

Also known as: Sunflower oil

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 12 and 18 years,
• Male and female
• Body mass Index (BMI) above the 95 percentile of the National Center for Health Statistics (NCHS) reference
• Informed consent form signed by both parents or legal guardian.

You may not qualify if:

• Those diagnosed as with Diabetes Mellitus Type 2 (DMT2), Cardiovascular disease (CVD) or kidney disease
• Those who are allergic to fish.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

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

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Docosahexaenoic Acids; Maxepa; Sunflower Oil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Limitations and Caveats

We completed sample size at recruitment, but only 67% completed follow-up. We did not continue recruitment because preliminary analyses suggested that a huge sample size would be necessary to detect differences in insulin resistance (IR) and BMI

Results Point of Contact

• Title: Dr. Mardia Guadalupe Lopez Alarcon
• Organization: Coordinacion de Investigacion en Salud, Mexico

marsau2@prodigy.net.mx

Study Officials

• Mardia Lopez-Alarcon, PhD

  Unit for Medical Research in Nutrition, Pediatric Hospital CMN "Siglo XXI"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 20, 2011
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 8, 2024
• Results First Posted: January 29, 2020

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)