Stress MentalNCT07715461
Effect of macaúba Oil Combined With Green Exercises
A study testing Macauba oil, Daytime Green Exercise and Nighttime Green Exercise in people with Stress Mental and Dyslipidemia, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Mental, Dyslipidemia, Obesity & Overweight
- What is being tested?
- Macauba oil, Daytime Green Exercise and Nighttime Green Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Aug 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites
Federal University of Paraíba
João Pessoa, Paraíba, 58051-900
Aline L Nascimento, MSc, +55 83991496161, alinenutri90@gmail.com
Aline L Nascimento, MSc
Institute of Agricultural Science - Universidade Federal de Minas Gerais
Montes Claros, Minas Gerais, 39401 - 001
BRUNA K BARBOSA, MSc, 38984047620, brunakaicy@outlook.com
BRUNA KAICY BARBOSA, MSc
About this study
Official title: Macaúba Oil and Green Exercises: Impacts on Lipid Oxidation and Mental Stress in Trained Individuals
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.
Read the 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.
- Conditions
- Stress Mental, Dyslipidemia, Obesity & Overweight
- Being tested
- Macauba oil, Placebo, Daytime Green Exercise, Nighttime Green Exercise
- Keywords
- Mitochondria, Lipid oxidation, Macauba oil, Fasting, Green exercises
- Medical subject headings
- Stress, Psychological, Dyslipidemias, Obesity, Overweight, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macauba oilDietary supplement
Macauba oil will be encapsulated in the form of a food supplement.
PlaceboDietary supplement
Placebo capsules containing mineral oil.
Daytime Green ExerciseBehavioural
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.
Nighttime Green ExerciseBehavioural
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.
| Study group | Role | What they receive |
|---|---|---|
| Macaúba oil + Daytime Green Exercise | Experimental | Participants will receive macauba oil capsules and will perform green exercises during the day. Receives: Dietary Supplement: Macauba oil; Behavioral: Daytime Green Exercise |
| Placebo + Daytime Green Exercise | Placebo comparator | Participants will receive placebo capsules and will perform green exercises during the day. Receives: Dietary Supplement: Placebo; Behavioral: Daytime Green Exercise |
| Macaúba oil + Nighttime Green Exercise | Experimental | Participants will receive macauba oil capsules and will perform green exercises during the night. Receives: Dietary Supplement: Macauba oil; Behavioral: Nighttime Green Exercise |
| Placebo + Nighttime Green Exercise | Placebo comparator | Participants will receive placebo capsules and will perform green exercises overnight. Receives: Dietary Supplement: Placebo; Behavioral: Nighttime Green Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose concentration (mg/dL)
Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Measured: Baseline and Week 8
Percentage of glycated hemoglobin (HbA1c) (%)
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
Measured: 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.
Measured: Baseline and Week 8
Plasma triglyceride concentration (mg/dL)
Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8
Secondary outcomes (5)
Body weight (Kg)
Body weight (kg) will be measured using a calibrated digital scale.
Measured: Baseline and Week 8
Total body fat percentage (%)
Total body fat percentage (%) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Measured: Baseline and Week 8
Total fat mass (Kg)
Total fat mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Measured: Baseline and Week 8
Lean body mass (kg)
Lean body mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA).
Measured: 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.
Measured: Before each exercise session and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress MentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be randomized, double-blind, and placebo-controlled. Participants will be randomly divided into four groups, with 15 participants in each.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Henrique Sousa Santos, Federal University of Minas Gerais
- Investigators
- Sérgio H Sousa Santos, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715461
- Sponsor's protocol ID
- 7.947.274
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macaúba Oil and Green Exercises: Impacts on Lipid Oxidation and Mental Stress in Trained Individuals
- ClinicalTrials.gov ID
- NCT07715461
- Acronym / sponsor ID
- 7.947.274
- Conditions
- Stress Mental, Dyslipidemia, Obesity & Overweight
- Keywords
- Mitochondria, Lipid oxidation, Macauba oil, Fasting, Green exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study will be randomized, double-blind, and placebo-controlled. Participants will be randomly divided into four groups, with 15 participants in each.
| Arm | Type | Receives |
|---|---|---|
| Macaúba oil + Daytime Green Exercise | Experimental | Dietary Supplement: Macauba oil, Behavioral: Daytime Green ExerciseParticipants will receive macauba oil capsules and will perform green exercises during the day. |
| Placebo + Daytime Green Exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Daytime Green ExerciseParticipants will receive placebo capsules and will perform green exercises during the day. |
| Macaúba oil + Nighttime Green Exercise | Experimental | Dietary Supplement: Macauba oil, Behavioral: Nighttime Green ExerciseParticipants will receive macauba oil capsules and will perform green exercises during the night. |
| Placebo + Nighttime Green Exercise | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Nighttime Green ExerciseParticipants will receive placebo capsules and will perform green exercises overnight. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macauba oilMacauba oil will be encapsulated in the form of a food supplement. | Dietary supplement | Macaúba oil + Daytime Green Exercise, Macaúba oil + Nighttime Green Exercise |
| PlaceboPlacebo capsules containing mineral oil. | Dietary supplement | Placebo + Daytime Green Exercise, Placebo + Nighttime Green Exercise |
| Daytime Green ExerciseParticipants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime. | Behavioural | Macaúba oil + Daytime Green Exercise, Placebo + Daytime Green Exercise |
| Nighttime Green ExerciseParticipants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime. | Behavioural | Macaúba oil + Nighttime Green Exercise, Placebo + Nighttime Green Exercise |
Primary outcome
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.
Percentage of glycated hemoglobin (HbA1c) (%)
Time frame: Baseline and Week 8
Glycosylated hemoglobin (HbA1c) (%) will be measured in whole blood.
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.
Plasma triglyceride concentration (mg/dL)
Time frame: Baseline and Week 8
Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay.
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.
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.
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sérgio H Sousa Santos, PhD principal investigator
Federal University of Minas Gerais
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macauba oil, Daytime Green Exercise and Nighttime Green Exercise in people with Stress Mental and Dyslipidemia, run by Federal University of Minas Gerais at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sérgio H Santos, PhD (+55 38999121055, sergiosousas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose concentration (mg/dL) (time frame: Baseline and Week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.