Obesity
Conditions
Interventions
This is a 9-month, randomized, crossover, crossover, four-step crossover clinical trial: 1st Run in: balanced hypoenergetic (DH) diet following the recommendations of the Brazilian guidelines for obes
2nd active treatment: DH + 200g complement (açaí or placebo)
3rd: washout (period without intervention) and 4th: crossover: DH + 200g of the complement. In the clinical trial, 224 individuals were screened, 93 being excluded because they did not meet the inclus
Dietary supplement
Other
D26.660
SP6.051.227
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Eligibility
Age
20 Years to 59 Years
Inclusion criteria
Inclusion criteria: overweight adults of both sexes, over 20 years of age, and who have dyslipidemia.
Exclusion criteria
Exclusion criteria: Individuals with aversion or food allergy known to açaí; Pregnant and lactating women, since the caloric restriction is not part of the food planning in these physiological conditions; Self-reported alcoholism, as it is related to the increase in blood pressure and to alter the concentration of serum lipoproteins that are parameters in the diagnosis of dyslipidemia; Individuals on an energy restriction diet or using dietary supplements containing minerals or antioxidant vitamins, as part of the present study weight loss and antioxidant supplementation, therefore, this aspect may interfere in the results of this study; Individuals with autoimmune, infectious, cancer and AIDS diseases that may interfere with the results of the present study; Thyroid diseases untreated and destabilized, since the thyroid regulates body metabolism, so in case of disease it may interfere in the results of the present study; Chronic renal failure or hepatopathies, because they are diseases that compromise the whole inflammatory state and oxidative stress, besides needing nutritional care that the protocol stipulated in this project is not able to supply; Use corticosteroid substances, as it interferes with the metabolism of glucose, causing hyperglycemia and edema, which may interfere with the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected results: improvement of the antioxidant capacity, verified by the dosage of isoprostane concentrations in the blood, being considered significant reductions, values of p less than 0,05; ;Increase in the expression of micro RNAs for the expression of antioxidant markers, evaluated by the measurement of açaí micro RNAs in the participants' blood, being considered significant increases, p values greater than 0.05;Decrease inflammatory markers, such as TNF alpha, interferon gamma, interleukin 1 and 6, being considered significant decreases, values of p less than 0.05 | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight loss, as measured by body mass in kilograms, and a reduction of 5 to 10% of the initial weight is expected.;Improvement of the lipid profile, evaluated by means of LDL, HDL, total cholesterol, VLDL and triglycerides, being considered significant reductions, p values less than 0.05. | — |
Countries
Brazil
Contacts
Public ContactGlorimar Rosa
universidade Federal do Rio de Janeiro
Outcome results
None listed