Effect of macaúba Oil Combined With Green Exercises
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-59
SponsorFederal University of Minas Gerais
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Macauba oil
Dietary supplementMacauba oil will be encapsulated in the form of a food supplement.
Placebo
Dietary supplementPlacebo capsules containing mineral oil.
Daytime Green Exercise
BehavioralParticipants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.
Nighttime Green Exercise
BehavioralParticipants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Macaúba oil + Daytime Green ExerciseExperimental treatment 2 interventions
Group B: Placebo + Daytime Green ExercisePlacebo comparator 2 interventions
Group C: Macaúba oil + Nighttime Green ExerciseExperimental treatment 2 interventions
Group D: Placebo + Nighttime Green ExercisePlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Fasting plasma glucose concentration (mg/dL)
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Time frame
Baseline and Week 82
Percentage of glycated hemoglobin (HbA1c) (%)
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
Time frame
Baseline and Week 83
Plasma concentrations of LDL cholesterol, HDL cholesterol, VLDL cholesterol, and total cholesterol (mg/dL)
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.
Time frame
Baseline and Week 84
Plasma triglyceride concentration (mg/dL)
Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Time frame
Baseline and Week 8Secondary outcomes
1
Body weight (Kg)
Body weight (kg) will be measured using a calibrated digital scale.
Time frame
Baseline and Week 82
Total body fat percentage (%)
Total body fat percentage (%) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame
Baseline and Week 83
Total fat mass (Kg)
Total fat mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame
Baseline and Week 84
Lean body mass (kg)
Lean body mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame
Baseline and Week 8Other outcomes
1
Pain perception score (Visual Analog Scale)
Pain perception will be assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame
Before each exercise session2
Perceived stress score (10-item Perceived Stress Scale )
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Scores range from 0 to 40, where higher scores indicate greater perceived stress.
Time frame
Baseline and Week 83
Mental health score: Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Mental health will be assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Domain scores range from 0 to 100, where higher scores indicate better health status and emotional well-being.
Time frame
Baseline and Week 8Sponsors and contacts
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Source ClinicalTrials.gov
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