Obesity
Conditions
Interventions
A double-blind, randomized, controlled clinical trial. The present study is based on the supplementation or not of freeze-dried Juçara pulp fruit without association with nutritional intervention in i
Dietary supplement
SP6.051.227
Sponsors
Universidade Federal de São Paulo - UNIFESP campus Baixada Santista
Universidade Federal de São Paulo - UNIFESP campus Baixada Santista
Eligibility
Age
30 Years to 59 Years
Inclusion criteria
Inclusion criteria: The study included volunteers with obesity (BMI between 30.0 and 39.9 kg / m2) with insufficiently active lifestyle, male and female, aged 31 to 59 years, according to the classification of the adult phase of the Organization World Health Organization (WHO, 2005).
Exclusion criteria
Exclusion criteria: Body mass index (BMI) below 29.9 kg/m2 or above 40.00 kg/m2; Infectious diseases and/or severe chronic diseases; Using medications that interfere with the inflammatory cascade, lipid metabolism and food consumption, such as statins, aspirins, hormones and/or antidepressants; Abuse of alcohol and drugs; - Pregnancy; Menopause.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistically significant (p <0.05) increase in gene and protein expression of epigenetic markers in monocytes of obese adult individuals due to supplemental consumption of lyophilized extract of Juçara palm pulp (Euterpe edulis Mart.). Gene expression of DNMT1, DNMT2, DNMT3a, DNMT3b, and MeCP2 will be evaluated by real-time polymerase chain reaction (RT-PCR). Protein expression will be from DNMT1, DNMT2, DNMT3a, DNMT3b, and MeCP2 will be evaluated by the Western blotting method. HDAC enzyme activity, as well as methylated DNA levels, will be evaluated by specific colorimetric method kits following the manufacturer's recommendations.;Statistically significant (p <0.05) reduction of protein and gene expression of inflammatory parameters in monocytes of obese adults due to supplemental consumption of a lyophilized extract from the pulp of the Juçara palm (Euterpe edulis Mart.). The gene expression of proteins involved in the TLR4 inflammatory pathway signaling cascade will be evaluated by real-time polymerase chain reaction (RT-PCR). Protein expression of proteins involved in the TLR4 inflammatory pathway signaling cascade will be evaluated by the Western blotting method. The production of inflammatory cytokines (MCP-1, IL10, IL6, and TNF?) will be evaluated by specific species ELISA method following the manufacturer's recommendations. | — |
Secondary
| Measure | Time frame |
|---|---|
| To verify a statistically significant difference (p <0.05) in the circulating fatty acid profile in the serum after supplementation of a lyophilized extract of the pulp of the Juçara palm fruit (Euterpe edulis Mart.) Reducing saturated and omega-6 fatty acid levels, increasing levels omega-3 and omega-9 fatty acids as well as the omega-3 / omega-6 ratio by the gas chromatography method.;To evaluate if the supplementation of a lyophilized extract of the pulp of the Juçara palm fruit (Euterpe edulis Mart.) Was able to promote weight loss and BMI reduction. Through anthropometric assessment of weight, height and waist circumference, verifying statistically significant difference (p <0.05) between before and after supplementation. | — |
Countries
Brazil
Contacts
Public ContactLuciana Pisani
Universidade Federal de São Paulo - UNIFESP campus Baixada Santista
Outcome results
None listed