metabolic syndrome
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. For this, 100 individuals classified as patients with metabolic syndrome will be divided into two groups: (50 patients in each) p
D10.251.355.325
Sponsors
Universidade Federal de Juiz de Fora
Universidade Federal de Juiz de Fora
Eligibility
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women between the ages of 30 and 65 with the ability to provide the Informed Consent Form; BMI (Body Mass Index) above 30 kg/m²; absence of any evidence of active coronary artery disease; presence of three or more of the following five Metabolic Syndromme criteria (IDF)
Exclusion criteria
Exclusion criteria: Individuals with fasting blood glucose greater than 300 mg/dL; limiting genetic and hormonal disease; smokers; abusive use of alcohol and drugs; pregnancy or lactation; refusal to provide a Free and Informed Consent Form; life expectancy less than 6 months (example: malignant neoplasm metastatic); renal failure with indication for dialysis; congestive heart failure; patients with previous organ transplantation; use of food supplements; exacerbated weight loss in the last 3 months (voluntary or involuntary); participation in another experimental study on the date of recruitment; use of lipid-lowering drugs or any medication for the treatment of diabetes with onset less than 3 months ago; non-steroidal anti-inflammatory drugs, corticosteroids or immunosuppressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expect outcome 1: As primary outcomes, it is expected that the intervention with avocado oil in obese patients with metabolic syndrome promotes the improvement of parameters related to insulin resistance (HOMA) and better glycemic control (glucose, glycated hemoglobin), in addition to improving inflammatory parameters ( reduction of interleukin-6 and TNF-alpha and increase of interleukin-10) and reduction of oxidative stress evaluated by oxidant markers: Dichlorohydrofluorescein (DCFH) and Nitric oxide (NO) and antioxidant: reduced glutathione (GSH). 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 parameters is statistically greater (p greater than 0.05) than that observed in the placebo.;Outcome 1: As primary outcomes found, intervention with avocado oil in obese patients with metabolic syndrome did not improve parameters related to insulin resistance (HOMA) and better glycemic control (glucose, glycated hemoglobin) and there was no improvement in inflammation (assessed by serum cytokines: interleukin-6, TNF-alpha, interleukin-10); and there was no improvement in oxidative stress assessed by oxidant markers: Dichlorohydrofluorescein (DCFH) and Nitric oxide (NO) and antioxidant: Reduced Glutathione (GSH). There was no statistical difference between the means of the mentioned parameters between the pre- and post-intervention periods. There was no statistical difference in the mentioned parameters compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expect outcome 2: As secondary outcomes, it is expected that anthropometric parameters (weight, BMI, waist circumference) and blood pressure measurement, with the use of avocado oil, in obese patients with metabolic syndrome, promote the improvement of these parameters. 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 parameters is statistically greater (p greater than 0.05) than that observed in the placebo.;Outcome 2: As secondary outcomes found, the intervention with avocado oil in obese patients with metabolic syndrome did not improve anthropometric parameters (weight, BMI, waist circumference) and blood pressure measurement. There was no statistically significant difference (p greater than 0.05) in the differences between the means of the mentioned parameters between the pre- and post-intervention periods. There was no statistical difference in the mentioned parameters compared to placebo. | — |
Countries
Brazil
Contacts
Public ContactClaudio De Souza
Universidade Federal de Juiz de Fora
Outcome results
None listed