An interventional study of Macauba oil and Placebo in Stress Mental, Dyslipidemia and Obesity & Overweight, sponsored by Federal University of Minas Gerais. Not yet recruiting at 2 sites in Brazil. Open to participants aged 35 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Prevention
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.
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.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive macauba oil capsules and will perform green exercises during the day.
Dietary Supplement: Macauba oil · Behavioral: Daytime Green Exercise
Participants will receive placebo capsules and will perform green exercises during the day.
Dietary Supplement: Placebo · Behavioral: Daytime Green Exercise
Participants will receive macauba oil capsules and will perform green exercises during the night.
Dietary Supplement: Macauba oil · Behavioral: Nighttime Green Exercise
Participants will receive placebo capsules and will perform green exercises overnight.
Dietary Supplement: Placebo · Behavioral: Nighttime Green Exercise
Macauba oil will be encapsulated in the form of a food supplement.
Placebo capsules containing mineral oil.
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.
Fasting plasma glucose concentration (mg/dL)
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Time frame: Baseline and Week 8
Percentage of glycated hemoglobin (HbA1c) (%)
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
Time frame: Baseline and Week 8
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 8
Plasma triglyceride concentration (mg/dL)
Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Time frame: Baseline and Week 8
Plasma malondialdehyde (MDA) concentration (nmol/mL)
Plasma malondialdehyde (MDA) concentration (nmol/mL) will be measured as a biomarker of lipid peroxidation.
Time frame: Baseline and Week 8
Erythrocyte glutathione peroxidase activity (U/g Hb)
Erythrocyte glutathione peroxidase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.
Time frame: Baseline and Week 8
Erythrocyte glutathione reductase activity (U/g Hb)
Erythrocyte glutathione reductase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.
Time frame: Baseline and Week 8
Plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L)
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Gamma-glutamyl transferase (GGT) (U/L) will be measured on plasma as an indicator of liver function.
Time frame: Baseline and Week 8
Body weight (Kg)
Body weight (kg) will be measured using a calibrated digital scale.
Time frame: Baseline and Week 8
Total body fat percentage (%)
Total body fat percentage (%) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame: Baseline and Week 8
Total fat mass (Kg)
Total fat mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame: Baseline and Week 8
Lean body mass (kg)
Lean body mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Time frame: Baseline and Week 8
Heart rate variability (HRV)
Heart rate variability parameters will be obtained using the Polar H10 heart rate sensor and analyzed with Kubios HRV software.
Time frame: Before each exercise session and Week 8
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 session
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 8
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 8
Plan to share: No — Individual participant data (IPD) will not be shared due to ethical and confidentiality considerations related to the protection of participants' personal information. The study results will be disclosed through publications and scientific presentations in aggregate form, ensuring that no individual participant can be identified.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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