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ObesityO3WLIRADOLNCT01456221

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

A study testing Omega3 and an hypocaloric diet. and Sunflower oil with an hypocaloric diet. in people with Obesity and Insulin Resistance, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Obesity, Insulin Resistance
What is being tested?
Omega3 and an hypocaloric diet. and Sunflower oil with an hypocaloric diet.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
1 siteMexico
Study dates
Jul 2012to Jan 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Unit or research in Medical Nutrition, Pediatric Hospital CMN "Siglo XXI", Instituto Mexicano del Seguro Social

    Mexico City, 06720

Other trials in Mexico

About this study

Official title: The Impact of Using omega3 Long-chain Polyunsaturated Fatty Acids in Weight Loss and Insulin Resistance in Obese Adolescents

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.

Read the 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 World Health Organization (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 body mass index (BMI), b) greater decreases in the mean fasting insulin concentration, homeostasis model assessment (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.

Being tested
Omega3 and an hypocaloric diet., Sunflower oil with an hypocaloric diet.
Keywords
Obesity, Insulin resistance, Omega3 long chain polyunsaturated fatty acids
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega3 and an hypocaloric diet.Dietary supplement

    Also called DHA and EPA fatty acids, Docosahexaenoic fatty acid, Eicosapentaenoic fatty acid, ®MaxEpa, Merck Laboratory

    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.

  • Sunflower oil with an hypocaloric diet.Dietary supplement

    Also called Sunflower oil

    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.

Study groups in NCT01456221
Study groupRoleWhat they receive
omega 3 and an hypocaloric dietExperimentalParticipants will receive a supplement containing omega 3: Docosahexaenoic acid (DHA) and EPA fatty acids together with an hypocaloric diet.
Receives: Dietary Supplement: Omega3 and an hypocaloric diet.
PlaceboPlacebo comparatorParticipants will receive a supplement containing sunflower oil with an hypocaloric diet.
Receives: Dietary Supplement: Sunflower oil with an hypocaloric diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Nutritional Status

    Nutritional status was determined by registering body mass index (BMI) calculated by formula: kg/m^2.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2011 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2015
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456221
Sponsor's protocol ID
R-2011-785-037
Acronym
O3WLIRADOL
Status last verified
Feb 2024
First submitted
12 Oct 2011
Last updated
8 Feb 2024
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Omega3 and an hypocaloric diet. and Sunflower oil with an hypocaloric diet. in people with Obesity and Insulin Resistance, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insulin Resistance (time frame: At baseline (at diagnosis), three months, throughout six months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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