NCT05759429

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 29, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

3.4 years

First QC Date

February 26, 2023

Last Update Submit

October 1, 2024

Conditions

Obesity

Keywords

ObesityMelatoninOxidative stressAdulthood

Outcome Measures

Primary Outcomes (4)

  • dROMS (reactive oxygen species) during physical exercise protocol

    Change in dROMS

    Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention

  • Malondialdehyde (MDA) during physical exercise protocol

    Change in malondialdehyde

    Baseline and after 30, 60, 90 and 120 minutes of the physical exercise protocol at day 15 of the intervention

  • Ratio of oxidized/reduced GSH (glutathione) during physical exercise protocol

    Change in ratio of oxidized/reduced GSH (glutathione)

    Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention

  • Plasma iron-reducing capacity (FRAP) during physical exercise protocol

    Change in plasma iron-reducing capacity (FRAP)

    Baseline (T0'), after 30 minutes of the physical exercise protocol (T30') and at T90' and T120' at day 1 and day 15 of the intervention

Secondary Outcomes (1)

  • Melatonin concentration

    Baseline (T0') and after 30 minutes of the physical exercise protocol (T30') at day 1 and day 15 of the intervention

Study Arms (2)

Integrated multidisciplinary body weight reduction program (BWRP)

ACTIVE COMPARATOR
Other: BWRP

Integrated multidisciplinary body weight reduction program (BWRP) + melatonin

ACTIVE COMPARATOR
Other: BWRP + melatonin

Interventions

BWRPOTHER

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

Integrated multidisciplinary body weight reduction program (BWRP)
BWRP + melatoninOTHER

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

Integrated multidisciplinary body weight reduction program (BWRP) + melatonin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index \> 30 kg/m2
  • absence of concomitant relevant diseases, apart severe obesity
  • hospitalized for a period of integrated metabolic rehabilitation

You may not qualify if:

  • \- concomitant relevant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Melatonin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Alessandro Sartorio, MD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

April 29, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Locations

IT(1)