Clinical trial

Effect of macaúba Oil Combined With Green Exercises

Opening soon · Not applicable · 1 countries · Registry ID NCT07715461

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 59 Years

SexAll

Healthy volunteersAccepted

ConditionStress Mental, Dyslipidemia, Obesity & Overweight

Full registry criteria

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.

Treatments and study arms

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

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Federal University of Paraíba🇧🇷 João Pessoa, Paraíba, Brazil

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Aline L Nascimento, MScContact

Email · Call +55 83991496161

Aline L Nascimento, MScPrincipal Investigator

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

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BRUNA K BARBOSA, MScContact

Email · Call 38984047620

BRUNA KAICY BARBOSA, MScPrincipal Investigator