Obesity
Conditions
Interventions
Double-blind clinical trial. Experimental group: women with obesity will receive individualized hypocaloric diet with supplementation of black soy, yellow soy or placebo (rice flour). The women will b
hypocaloric diet+ yellow soy supplement and hypocaloric diet (20 participants) + placebo (rice flour) (20 participants). The intervention will be followed by the participants for a period of 12 weeks.
B01.650.940.800.575.912.250.401.750
Sponsors
Universidade Federal do Rio de Janeiro
Empresa Brasileira de Pesquisa Agropecuária - EMBRAPA
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: women; adults; any race or color
Exclusion criteria
Exclusion criteria: pregnant women; lactating women; smokers; hepatopathic patients; cardiopathic patients; nephropathic patients; patients with unstable thyroid disorders; cancer; inflammatory bowel disease; food allergy/intolerance; bariatric patients who have changed more than 3 kg in the last 2 months; patients taking food supplements for three months before or during the study; patients taking anti-depressant or weight loss medications; suspected binge eating; non-compliance with the study protocol or who present complications that make it impossible to meet the eligibility criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Expected Results. Relationship with greater body weight loss. Presentation of the expected outcome is to assess that consumption of black soy may be related to greater body weight loss and improved lipid and glycemic profile, due to the effect of anthocyanins in reducing systemic inflammation. Considering that black soy has been marketed and used with functional claims in obesity, we believe that our results may contribute to add scientific evidence to support its use in the control of obesity and related diseases. Thus, new findings will contribute to dietary prescription applied to obesity control at the clinical and collective level, since this is a randomized, human controlled clinical trial. Regarding yellow soy, there are already more studies and it seems that its effect on weight loss is discrete, especially considering the fiber content, in addition to the benefit in dyslipidemia control. Therefore, it is expected that the greatest weight loss and glycemic and lipemic control will be observed in the group that will use the black soy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary Outcomes. Metabolic improvement (lipid profile - total cholesterol, non-hdl cholesterol, hdl, ldl, vldl, triglycerides and glycemic profile - insulin, fasting glucose, glycated hemoglobin, homa-ir) | — |
Countries
Brazil
Contacts
Public ContactCaroline Fogassa
Universidade Federal do Rio de Janeiro
Outcome results
None listed