Obesity
Conditions
Interventions
Volunteers will be randomized into four groups. Omega and physical activity group: 25 obese adults and type 2 diabetics will receive, per day, 4 omega-3 capsules containing 1000mg, with 360mg of eicos
Sponsors
Universidade Federal de Juiz de Fora
Universidade Federal de Juiz de Fora
Eligibility
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Both sexes; age between 20 and 60 years; diagnosis of grade I obesity (Body Mass Index between 30.0 and 34.9 kg/m²) and type 2 diabetes mellitus; exclusive use of metformin; no evidence of coronary artery disease (history of angina, history of myocardial infarction or acute coronary syndrome, history of abnormal segmental motion of the heart wall on echocardiography); no bowel disease (short bowel syndrome, irritable bowel syndrome, Chron's disease, ulcerative colitis, celiac disease, colorectal cancer); no diseases related to the central nervous system (Alzheimer's, Parkinson's, hepatic encephalopathy, autism spectrum disorders); physical inactivity according to the International Physical Activity Questionnaire (short version); signing the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Individuals with musculoskeletal or cardiovascular limitations that make physical exercise impossible; fasting blood glucose greater than 300 mg/dl; use of any drug of continuous use for less than 3 months (except metformin); use of antibiotics, non-steroidal anti-inflammatory drugs or corticosteroids in the last month; use vitamin/food supplements that contain omega-3; individuals with genetic and hormonal limiting disease; abuse of alcohol and drugs; retinopathy; pregnancy or lactation; life expectancy less than 6 months (example: metastatic malignant neoplasm); patients with renal failure or congestive heart failure; individuals with previous organ transplants; wheelchair users; individuals with weight loss in the last 3 months (voluntary or not); volunteers in another experimental study on the date of enrollment; individuals who do not have access to the internet; discontinuation of omega-3/placebo use for 3 consecutive days; non-compliance with the physical activity protocol for 2 consecutive sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary outcomes, it is expected that the intervention with fish oil rich in omega 3 associated with the proposed exercise protocol, in obese and diabetic patients, promotes a reduction in the levels of parameters related to insulin resistance (glycemia, insulin, glycated hemoglobin and in the insulin resistance homeostasis assessment model), in conjunction with reduced levels of interleukin 6 and tumor necrosis factor alpha. A statistically significant difference (p greater than 0.05) is expected in the differences between the means of the mentioned parameters between the pre- and post-intervention periods. It is also believed that the reduction of the mentioned biochemical parameters will be statistically greater (p greater than 0.05) than that observed in the other groups evaluated (placebo group or isolated interventions with fish oil rich in omega 3 or exercise protocol). | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes, it is expected that the anthropometric parameters (weight, body mass index, triceps skinfold and arm and waist circumferences) and body composition (body fat percentage) show a reduction as well as an increase in anti-inflammatory interleukin 10 levels, after the intervention with fish oil rich in omega 3 combined with the exercise protocol, both with a statistically significant difference (p greater than 0.05). For both outcomes described, the expected statistical difference will be evaluated (after application of a normality test) by a dependent sample comparison test (for comparison between pre- and post-intervention periods) or by independent sample tests (for comparison of results after the intervention between the different groups). | — |
Countries
Brazil
Contacts
Public ContactClaudio de Souza
Universidade Federal de Juiz de Fora
Outcome results
None listed