Dyslipidemia, Obesity & Overweight, Stress Mental
Conditions
Keywords
Mitochondria, Lipid oxidation, Macauba oil, Fasting, Green exercises
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.
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.
Interventions
DIETARY_SUPPLEMENTMacauba oil
Macauba oil will be encapsulated in the form of a food supplement.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules containing mineral oil.
BEHAVIORALDaytime Green Exercise
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the daytime.
BEHAVIORALNighttime Green Exercise
Participants will perform supervised moderate-intensity exercise outdoors in a green environment during the nighttime.
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose concentration (mg/dL) | Baseline and Week 8 | Plasma glucose concentration (mg/dL) will be measured using an enzymatic colorimetric assay. |
| Percentage of glycated hemoglobin (HbA1c) (%) | 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) | 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) | Baseline and Week 8 | Plasma triglyceride concentration (mg/dL) will be measured using an enzymatic colorimetric assay. |
| Plasma malondialdehyde (MDA) concentration (nmol/mL) | 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) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Body weight (Kg) | Baseline and Week 8 | Body weight (kg) will be measured using a calibrated digital scale. |
| Total body fat percentage (%) | Baseline and Week 8 | Total body fat percentage (%) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA). |
| Total fat mass (Kg) | Baseline and Week 8 | Total fat mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA). |
| Lean body mass (kg) | Baseline and Week 8 | Lean body mass (kg) will be assessed by Dual-Energy X-ray Absorptiometry (DEXA). |
| Heart rate variability (HRV) | 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. |
Countries
Brazil
Contacts
CONTACTSérgio H Santos, PhD
CONTACTBruna K Barbosa, MSc
PRINCIPAL_INVESTIGATORSérgio H Sousa Santos, PhD
Federal University of Minas Gerais
Outcome results
None listed