Diabetes Mellitus, Type 2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This research will include patients over 18 years of age with DM2 who spontaneously want to participate in the study, signing the consent and clarification term (ICF). It is worth mentioning that at any time the selected individuals may abandon the research without prejudice to their treatments.
Exclusion criteria
Exclusion criteria: Patients using insulin; Patients unable to complete the questions as a result of linguistic difficulties, education or unable to attend the previously scheduled assessments; Patients who do not consume fruits of Araça or Butia Patients who have a BMI greater than 35 kg / m2 and have other concomitant health problems. Patients who do not feel comfortable with the research criteria and do not want to participate in the study or do not sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of consumption of Araçá Vermelho (Psidium cattleyanum Sabine) and Butiá (Butia capitata) pulps on glycemic and lipid profiles, and on oxidative stress biomarkers in individuals with type II diabetes mellitus (DM2). A randomized, controlled, parallel, open, interventional treatment trial will be conducted with three arms with 60 patients with DM2, divided into 3 groups: Control group and Intervention group with araçá or butia. Individuals will ingest 50 g / day of the fruit pulp for 60 days. Blood samples will be collected at the beginning of the study and after 30 and 60 days of treatments to assess: fasting glucose, glycated hemoglobin A1c (HbA1c), fructosamine, total cholesterol (CT), triglycerides, high-density lipoprotein-cholesterol (HDL- c), low-density lipoprotein-cholesterol (LDL-c), total antioxidant capacity (TAC), total oxidative state (TOS), oxidative stress index (IEO), total phenolic compounds, glutathione reductase (GSH) and activity of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GPx) enzymes. Anthropometric, clinical and food intake parameters will also be assessed at the beginning of the study and after 30 and 60 days of treatment. Patients who consumed the pulps of native fruits significantly reduced glycemic parameters: 25% in fasting glucose levels, 29% in HbA1c, 19.9% ??in fructosamine; lipid parameters: 7.8% in total cholesterol (TC), 5.1% in triglycerides; clinical parameters: 11.2% in SBP (systolic blood pressure), 13.3% in DBP (diastolic blood pressure); anthropometric parameters: 2.04% in body weight, 1.2% in body mass index (BMI), 6.6% in waist circumference (WC); 15.6% in the total caloric value of the diet (VCT) (p 0.05). The results indicated a positive impact on regular consumption of native fruits on HDL-c levels, as well as on phenolic compounds, enzymatic and non-enzymatic endogenous antioxidant system, which can contribute to the health of the cardiovascular system, and reduce the | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Universidade do Planalto Catarinense