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Effect of Melatonin on Oxidative Stress in Obese Adults (MELASTRESSOB)

NCT05759429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-02

No results posted yet for this study

Summary

The present research project aims to evaluate oxidative stress in a cohort of obese adults, subjected to an in-hospital 3-week multidisciplinary body weight reduction program (BWRP) with or without melatonin. Our hypothesis is that melatonin, administered to the obese subject, could be effective in reducing the oxidative stress associated with physical exercise (acute).

Specifically, the main objective will be to investigate a difference in the mean levels of some peripheral oxidative stress markers at their peak during an acute exercise session in the two groups (primary endpoint).

Secondly, the possible pre-post difference (baseline vs end of treatment) of the peak of each oxidative stress marker between the two groups will be evaluated (secondary endpoint

Conditions

Interventions

OTHER

BWRP

Physical exercise protocol after 1 and 15 days of integrated multidisciplinary BWRP, which includes a low-calorie diet, physical activity, psychological support, and nutritional education

OTHER

BWRP + melatonin

Physical exercise protocol after 1 and 15 days of integrated multidisciplinary BWRP and melatonin (4 mg/die), administered 2-3 hours before bedtime

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Alessandro Sartorio, MD · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759429 on ClinicalTrials.gov