Effects of Omega-3 Supplementation, associated or not with Physical Exercise in patients with Metabolic Syndrome

Not Applicable

• Conditions: Obesity; diabetes mellitus type 2; insulin resistance; inflammation; C18.452.394.968.500.570

• Registration Number: RBR-8cb536g
• Lead Sponsor: niversidade Federal de Juiz de Fora

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 29 May 2023
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).