Effect of macaúba Oil Combined With Green Exercises

Официальное название

Macaúba Oil and Green Exercises: Impacts on Lipid Oxidation and Mental Stress in Trained Individuals

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Macauba oil
  Macauba oil will be encapsulated in the form of a food supplement.
• Пищевая добавка Placebo
  Placebo capsules containing mineral oil.
• Поведенческое Daytime Green Exercise
  Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.
• Поведенческое Nighttime Green Exercise
  Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.

Первичные конечные точки

• Fasting plasma glucose concentration (mg/dL) [Срок оценки: Baseline and Week 8]
• Percentage of glycated hemoglobin (HbA1c) (%) [Срок оценки: Baseline and Week 8]
• Plasma concentrations of LDL cholesterol, HDL cholesterol, VLDL cholesterol, and total cholesterol (mg/dL) [Срок оценки: Baseline and Week 8]
• Plasma triglyceride concentration (mg/dL) [Срок оценки: Baseline and Week 8]
• Plasma malondialdehyde (MDA) concentration (nmol/mL) [Срок оценки: Baseline and Week 8]
• Erythrocyte glutathione peroxidase activity (U/g Hb) [Срок оценки: Baseline and Week 8]
• Erythrocyte glutathione reductase activity (U/g Hb) [Срок оценки: Baseline and Week 8]
• Plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L) [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (5)

• Body weight (Kg) [Срок оценки: Baseline and Week 8]
• Total body fat percentage (%) [Срок оценки: Baseline and Week 8]
• Total fat mass (Kg) [Срок оценки: Baseline and Week 8]
• Lean body mass (kg) [Срок оценки: Baseline and Week 8]
• Heart rate variability (HRV) [Срок оценки: Before each exercise session and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 2 центра

• Institute of Agricultural Science - Universidade Federal de Minas Gerais — Montes Claros
• Federal University of Paraíba — João Pessoa

Идентификаторы

NCT: NCT07715461 · 7.947.274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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