Effect of macaúba Oil Combined With Green Exercises
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Macauba oil, Placebo, Daytime Green Exercise, Nighttime Green Exercise.
- Who it may be relevant to
- Registry conditions: Stress Mental, Dyslipidemia, Obesity & Overweight. Basic parameters: 35 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Macaúba Oil and Green Exercises: Impacts on Lipid Oxidation and Mental Stress in Trained Individuals
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Macauba oil
Macauba oil will be encapsulated in the form of a food supplement. - Dietary supplement Placebo
Placebo capsules containing mineral oil. - Behavioral Daytime Green Exercise
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime. - Behavioral Nighttime Green Exercise
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.
Primary outcome measures
- Fasting plasma glucose concentration (mg/dL) [Time frame: Baseline and Week 8]
- Percentage of glycated hemoglobin (HbA1c) (%) [Time frame: Baseline and Week 8]
- Plasma concentrations of LDL cholesterol, HDL cholesterol, VLDL cholesterol, and total cholesterol (mg/dL) [Time frame: Baseline and Week 8]
- Plasma triglyceride concentration (mg/dL) [Time frame: Baseline and Week 8]
- Plasma malondialdehyde (MDA) concentration (nmol/mL) [Time frame: Baseline and Week 8]
- Erythrocyte glutathione peroxidase activity (U/g Hb) [Time frame: Baseline and Week 8]
- Erythrocyte glutathione reductase activity (U/g Hb) [Time frame: Baseline and Week 8]
- Plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L) [Time frame: Baseline and Week 8]
Secondary outcome measures (5)
- Body weight (Kg) [Time frame: Baseline and Week 8]
- Total body fat percentage (%) [Time frame: Baseline and Week 8]
- Total fat mass (Kg) [Time frame: Baseline and Week 8]
- Lean body mass (kg) [Time frame: Baseline and Week 8]
- Heart rate variability (HRV) [Time frame: Before each exercise session and Week 8]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Brazil · 2 centers
- Institute of Agricultural Science - Universidade Federal de Minas Gerais — Montes Claros
- Federal University of Paraíba — João Pessoa
Identifiers
NCT: NCT07715461 · 7.947.274