NCT07715461

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

June 30, 2026

Last Update Submit

July 16, 2026

Conditions

Stress MentalDyslipidemiaObesity & Overweight

Keywords

MitochondriaLipid oxidationMacauba oilFastingGreen exercises

Outcome Measures

Primary Outcomes (8)

  • Fasting plasma glucose concentration (mg/dL)

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

    Baseline and Week 8

  • Percentage of glycated hemoglobin (HbA1c) (%)

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

    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.

    Baseline and Week 8

  • Plasma triglyceride concentration (mg/dL)

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

    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.

    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.

    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.

    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.

    Baseline and Week 8

Secondary Outcomes (5)

  • Body weight (Kg)

    Baseline and Week 8

  • Total body fat percentage (%)

    Baseline and Week 8

  • Total fat mass (Kg)

    Baseline and Week 8

  • Lean body mass (kg)

    Baseline and Week 8

  • Heart rate variability (HRV)

    Before each exercise session and Week 8

Other Outcomes (3)

  • Pain perception score (Visual Analog Scale)

    Before each exercise session

  • Perceived stress score (10-item Perceived Stress Scale )

    Baseline and Week 8

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

    Baseline and Week 8

Study Arms (4)

Macaúba oil + Daytime Green Exercise

EXPERIMENTAL

Participants will receive macauba oil capsules and will perform green exercises during the day.

Dietary Supplement: Macauba oilBehavioral: Daytime Green Exercise

Placebo + Daytime Green Exercise

PLACEBO COMPARATOR

Participants will receive placebo capsules and will perform green exercises during the day.

Dietary Supplement: PlaceboBehavioral: Daytime Green Exercise

Macaúba oil + Nighttime Green Exercise

EXPERIMENTAL

Participants will receive macauba oil capsules and will perform green exercises during the night.

Dietary Supplement: Macauba oilBehavioral: Nighttime Green Exercise

Placebo + Nighttime Green Exercise

PLACEBO COMPARATOR

Participants will receive placebo capsules and will perform green exercises overnight.

Dietary Supplement: PlaceboBehavioral: Nighttime Green Exercise

Interventions

Macauba oilDIETARY_SUPPLEMENT

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

Macaúba oil + Daytime Green ExerciseMacaúba oil + Nighttime Green Exercise
PlaceboDIETARY_SUPPLEMENT

Placebo capsules containing mineral oil.

Placebo + Daytime Green ExercisePlacebo + Nighttime Green Exercise
Nighttime Green ExerciseBEHAVIORAL

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

Macaúba oil + Nighttime Green ExercisePlacebo + Nighttime Green Exercise
Daytime Green ExerciseBEHAVIORAL

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

Macaúba oil + Daytime Green ExercisePlacebo + Daytime Green Exercise

Eligibility Criteria

Age35 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Agricultural Science - Universidade Federal de Minas Gerais

Montes Claros, Minas Gerais, 39401 - 001, Brazil

Location

Federal University of Paraíba

João Pessoa, Paraíba, 58051-900, Brazil

Location

MeSH Terms

Conditions

Stress, PsychologicalDyslipidemiasObesityOverweightFasting

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding Behavior

Study Officials

  • Sérgio H Sousa Santos, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sérgio H Santos, PhD

CONTACT

+55 38999121055sergiosousas@hotmail.com

Bruna K Barbosa, MSc

CONTACT

+55 38 98404-7620brunakaicy@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study will be randomized, double-blind, and placebo-controlled. Participants will be randomly divided into four groups, with 15 participants in each.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 20, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

BR(2)