Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents (O3WLIRADOL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Coordinación de Investigación en Salud, Mexico
Sponsor:
Information provided by (Responsible Party):
Mardia Guadalupe Lopez Alarcon, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01456221
First received: October 12, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
Dietary Supplement: Omega3 and an hypocaloric diet.
Dietary Supplement: Sunflower oil with an hypocaloric diet.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Impact of Using omega3 Long-chain Polyunsaturated Fatty Acids in Weight Loss and Insulin Resistance in Obese Adolescents

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Change in Insulin Resistance [ Time Frame: At baseline (at diagnosis) throughout six months. ] [ Designated as safety issue: No ]
    Change from baseline in insulin resistance at three and six months. Changes in insulin resistance will be evaluated through fasting insulin and HOMA index.


Secondary Outcome Measures:
  • Nutritional status [ Time Frame: At baseline (at diagnosis) throughout six months. ] [ Designated as safety issue: No ]
    Nutritional status will be determined by registering anthropometrical measurements: weight, stature, body mass index, waist.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega 3 and an hypocaloric diet
Participants will receive a supplement containing omega 3: DHA and EPA fatty acids together with an hypocaloric diet.
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.
Other Names:
  • DHA and EPA fatty acids
  • Docosahexaenoic fatty acid
  • Eicosapentaenoic fatty acid
  • ®MaxEpa, Merck Laboratory
Placebo Comparator: Placebo
Participants will receive a supplement containing sunflower oil with an hypocaloric diet.
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.
Other Name: Sunflower oil

Detailed Description:

Background: In 2006, the prevalence of overweight and obesity combined in scholar and adolescents in Mexico was 26% and 31% respectively, which represents more than double of that reported in year 2000. Together with such increments in the obesity rates, it was observed similar increases in the incidence of other metabolic conditions such as insulin resistance (IR). In a very simplistic manner, it seems that the link between obesity and IR is a chronic inflammatory status because the adipose tissue-derived inflammatory molecules interfere with the uptake of fatty acids and glucose in peripheral tissues.

On the other hand, it is accepted that the long-chain polyunsaturated fatty acids (LCPUFA) omega-3 exhibit anti-inflammatory properties. In addition, it has been also demonstrated the beneficial effect exerted by such fatty acids on insulin sensitivity, and in stabilizing the weight lost achieved with hypocaloric diets.

At present, the prevalence of overweight and obesity combined are in the range of 41-43% in the adolescent population that attend the four areas of influence of the Mexican Institute of Social Security (IMSS) in Mexico City. Interventions addressed to improve the nutritional status of these groups of age are expected to impact the risk for IR and its associated co-morbidities.

Objective: To evaluate the impact of supplementation with LCPUFA omega-3, together with a dietary strategy, on obesity and insulin resistance in a sample of obese adolescents attended in the IMSS.

Methods: In a randomized clinical design, 300 obese individuals, 12-18 years old, will be selected. At selection, individuals will be randomly assigned to receive daily a capsule with 1.1 g LCPUFA omega-3 during three mo together with a hypocaloric diet which follows the WHO recommendations (D+O3), or to receive daily a capsule with 1.0 g sunflower oil and a similar diet (P+D). After randomization, dietary information (24h-recall and FFQ), anthropometric measurements, and peripheral blood samples, will be obtained. Blood samples will be used to determine fasting plasma glucose and insulin, and erythrocytes fatty acid profile; such determinations will be repeated at three and six mo of follow-up. Anthropometry and 24 h-recalls will be repeated monthly.

For follow-up, studied subjects will be evaluated monthly to deliver capsules and to check for dietary adherence. Treatments will be administered during three months and the follow-up will continue throughout six months. At the end of the follow-up it is expect that the D+O3 group will present: a) higher decreases in mean weight and BMI, b) greater decreases in the mean fasting insulin concentration, HOMA index, and IR frequency, c) longer duration of weight lost.

Statistical analyses: Student and paired-t test will be used for inter and intra group comparisons respectively. Logistic regression models and repeated measures analyses will be conducted to evaluate the effect of treatments, adjusting by diet and weight loss, as well as by confounders such as puberty and treatment adherence.

Infrastructure: The Unit of Research in Medical Nutrition owes the equipment needed to conduct the laboratory determinations proposed in this research, as well as the personnel qualified to conduct, monitor, analyze and evaluate data from field investigation, specially that related to obesity and IR.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 12 and 18 years,
  • Male and female
  • IMC above the 95 percentile of the NCHS reference
  • Informed consent form signed by both parents or legal guardian.

Exclusion Criteria:

  • Those diagnosed as with DMT2, ECV or kidney disease
  • Those who are allergic to fish.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456221

Contacts
Contact: Mardia Lopez-Alarcon, PhD (52)(55) 56276944 marsau2@prodigy.net.mx

Locations
Mexico
Unit or research in Medical Nutrition, Pediatric Hospital CMN "Siglo XXI", Instituto Mexicano del Seguro Social Recruiting
Mexico City, Mexico, 06720
Contact: Mardia Lopez-Alarcon, PhD    (52)(55) 56276900    marsau2@prodigy.net.mx   
Principal Investigator: Mardia Lopez-Alarcon, PhD         
Sub-Investigator: Enrique Rendon- Macias, PhD         
Sub-Investigator: Marisela Rodriguez-Cruz, PhD         
Sub-Investigator: Maria de Lourdes Barbosa-Cortes, MSc         
Sub-Investigator: Mariela Bernabe Garcia, MSc         
Sub-Investigator: Jorge Maldonado-Hernandez, MSc         
Sub-Investigator: Patricia Inda-Icaza, MSc         
Sub-Investigator: Ivan Hernandez-Hernandez         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Mardia Lopez-Alarcon, PhD Unit for Medical Research in Nutrition, Pediatric Hospital CMN "Siglo XXI"
  More Information

No publications provided

Responsible Party: Mardia Guadalupe Lopez Alarcon, Doctor, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01456221     History of Changes
Other Study ID Numbers: R-2011-785-037
Study First Received: October 12, 2011
Last Updated: July 23, 2014
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Obesity
Insulin resistance
Omega3 long chain polyunsaturated fatty acids

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Weight Loss
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014