Macaúba Oil and Green Exercises: Impacts on Lipid Oxidation and Mental Stress in Trained Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fasting plasma glucose concentration (mg/dL)
研究概览
简要总结
Animal model studies involving macaúba oil demonstrate beneficial effects on fat, oxidative stress, and adipogenesis. This study aims to evaluate lipid oxidation and mental stress levels in trained individuals following macaúba oil supplementation combined with outdoor exercise (green exercise) performed in a fasted state. The study will be randomized, double-blind, and placebo-controlled. Participants will receive either 400 mg of macaúba oil or placebo pills over an 8-week period while engaging in 5 km running sessions four times a week. Assessments of anthropometric parameters, body composition (DEXA), biochemical parameters, and heart rate will be conducted before and after the intervention, alongside the administration of a questionnaire regarding emotional well-being and perceived stress. At the end of the intervention, results will be analyzed using Kubios HRV 2.0 and GraphPad Prism (version 5.0) software; the Kolmogorov-Smirnov and Shapiro-Wilk tests will be applied to verify data normality, the Student's t-test for parametric data, and the Kruskal-Wallis and Wilcoxon-Mann-Whitney tests for non-parametric data.
详细描述
Preclinical studies evaluating the acute and subacute toxicity of macaúba oil showed no adverse effects at dosages of up to 1000 mg/kg. Therefore, the macaúba capsule dosage will be 400 mg/day, based on similar studies previously conducted with other oils where this dosage yielded positive health effects without adverse consequences. The training program will last a total of 8 weeks. Before each running session, analog scales will be used to subjectively assess perceived pain, alongside assessments of Heart Rate Variability (HRV) and alpha asymmetry. HRV will be monitored using the Polar H10 sensor and the Elite HRV app, both connected via Bluetooth. Blood samples will be collected for laboratory analysis using specific enzymatic kits (Wiener Lab.®, Argentina) to measure glucose, glycated hemoglobin (HbA1c), LDL cholesterol, HDL cholesterol, VLDL cholesterol, non-HDL cholesterol, total cholesterol, triglycerides, MDA, erythrocyte glutathione peroxidase, erythrocyte glutathione reductase, glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, and gamma-GT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 35 to 59 years
- •Body mass index (BMI) below 30 m/kg²
- •Body fat below 25%, with stability of body mass in the last six months
- •Being physically active (performing moderate physical activity or <75 min / being vigorous physical activity)
- •Being apparently healthy according to the Physical Activity Readiness Questionnaire.
排除标准
- •Musculoskeletal injury that limits the ability to exercise at moderate intensity during the study period
- •Use of supplements, anti-inflammatory drugs and/or analgesics during the study period
- •Use of any therapy for muscle pain during the study period.
结局指标
主要结局
Fasting plasma glucose concentration (mg/dL)
时间窗: Baseline and Week 8
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Percentage of glycated hemoglobin (HbA1c) (%)
时间窗: Baseline and Week 8
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
Plasma concentrations of LDL cholesterol, HDL cholesterol, VLDL cholesterol, and total cholesterol (mg/dL)
时间窗: Baseline and Week 8
Plasma low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol and total cholesterol concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Plasma triglyceride concentration (mg/dL)
时间窗: Baseline and Week 8
Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Plasma malondialdehyde (MDA) concentration (nmol/mL)
时间窗: Baseline and Week 8
Plasma malondialdehyde (MDA) concentration (nmol/mL) will be measured as a biomarker of lipid peroxidation.
Erythrocyte glutathione peroxidase activity (U/g Hb)
时间窗: Baseline and Week 8
Erythrocyte glutathione peroxidase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.
Erythrocyte glutathione reductase activity (U/g Hb)
时间窗: Baseline and Week 8
Erythrocyte glutathione reductase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.
Plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L)
时间窗: Baseline and Week 8
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Gamma-glutamyl transferase (GGT) (U/L) will be measured on plasma as an indicator of liver function.
次要结局
- Total fat mass (Kg)(Baseline and Week 8)
- Body weight (Kg)(Baseline and Week 8)
- Total body fat percentage (%)(Baseline and Week 8)
- Lean body mass (kg)(Baseline and Week 8)
- Heart rate variability (HRV)(Before each exercise session and Week 8)
研究者
Sergio Henrique Sousa Santos
Principal Investigator
Federal University of Minas Gerais