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NCT Number: NCT07715461

Effect of macaúba Oil Combined With Green Exercises

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.

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Key information

Conditions

Stress Mental Behavior Behavioral Symptoms Body Weight Dyslipidemia Dyslipidemias Fasting Feeding Behavior Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

35 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Agricultural Science - Universidade Federal de Minas Gerais, Montes Claros, Minas Gerais, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Macauba oil

Dietary Supplement

Macauba oil will be encapsulated in the form of a food supplement.

Placebo

Dietary Supplement

Placebo capsules containing mineral oil.

Daytime Green Exercise

Behavioral

Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.

Nighttime Green Exercise

Behavioral

Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.

Primary outcomes

  1. Fasting plasma glucose concentration (mg/dL)

    Time frame: Baseline and Week 8

    Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.

  2. Percentage of glycated hemoglobin (HbA1c) (%)

    Time frame: Baseline and Week 8

    Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.

  3. Plasma concentrations of LDL cholesterol, HDL cholesterol, VLDL cholesterol, and total cholesterol (mg/dL)

    Time frame: 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.

  4. Plasma triglyceride concentration (mg/dL)

    Time frame: Baseline and Week 8

    Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.

  5. Plasma malondialdehyde (MDA) concentration (nmol/mL)

    Time frame: Baseline and Week 8

    Plasma malondialdehyde (MDA) concentration (nmol/mL) will be measured as a biomarker of lipid peroxidation.

  6. Erythrocyte glutathione peroxidase activity (U/g Hb)

    Time frame: Baseline and Week 8

    Erythrocyte glutathione peroxidase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.

  7. Erythrocyte glutathione reductase activity (U/g Hb)

    Time frame: Baseline and Week 8

    Erythrocyte glutathione reductase activity (U/g Hb) will be measured as a biomarker of antioxidant defense.

  8. Plasma aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L)

    Time frame: 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.

Secondary outcomes

  1. Body weight (Kg)

    Time frame: Baseline and Week 8

    Body weight (kg) will be measured using a calibrated digital scale.

  2. Total body fat percentage (%)

    Time frame: Baseline and Week 8

    Total body fat percentage (%) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).

  3. Total fat mass (Kg)

    Time frame: Baseline and Week 8

    Total fat mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).

  4. Lean body mass (kg)

    Time frame: Baseline and Week 8

    Lean body mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).

  5. Heart rate variability (HRV)

    Time frame: Before each exercise session and Week 8

    Heart rate variability parameters will be obtained using the Polar H10 heart rate sensor and analyzed with Kubios HRV software.

Other outcomes

  1. Pain perception score (Visual Analog Scale)

    Time frame: Before each exercise session

    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.

  2. Perceived stress score (10-item Perceived Stress Scale )

    Time frame: Baseline and Week 8

    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.

  3. Mental health score: Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline and Week 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna K Barbosa, MSc

CONTACT

[email protected]

+55 38 98404-7620

Sérgio H Santos, PhD

CONTACT

[email protected]

+55 38999121055

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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