N/A
Completed N=366
Intervention Study With Omega-3 Fatty Acids for Weight Loss and Insulin Resistance in Adolescents
Source: ClinicalTrials.gov NCT01456221 ↗Enrolled (actual)
366
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change in Insulin Resistance — 7.38; 6.89; 6.73; 6.28 HOMA-IR Index
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Resistance |
7.38; 6.89; 6.73; 6.28; 6.02; 5.41 | — |
| SECONDARY Nutritional Status |
31.53; 31.16; 30.89; 30.40; 31.1; 30.25 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Those diagnosed as with Diabetes Mellitus Type 2 (DMT2), Cardiovascular disease (CVD) or kidney disease
- Those who are allergic to fish.
Data sourced from ClinicalTrials.gov (NCT01456221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.