Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals

NCT ID: NCT05758363

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment.

Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

Consumption of dietary supplement capsules for 6 months.

Group Type EXPERIMENTAL

Consumption of dietary supplement.

Intervention Type DIETARY_SUPPLEMENT

Consumption of a dietary supplement rich in glutathione, selenium, zinc, vitamin D and EPA/DHA. 1 capsule per day of the dietary supplement with breakfast.

Control Group

Identically appearing placebo capsules consumed for 6 months.

Group Type PLACEBO_COMPARATOR

Consumption of control product

Intervention Type OTHER

Consumption of 1 capsule per day of control product of identical appearance with breakfast.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Consumption of dietary supplement.

Consumption of a dietary supplement rich in glutathione, selenium, zinc, vitamin D and EPA/DHA. 1 capsule per day of the dietary supplement with breakfast.

Intervention Type DIETARY_SUPPLEMENT

Consumption of control product

Consumption of 1 capsule per day of control product of identical appearance with breakfast.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults (age: 30 - 70 YO)
* BMI over 25 kg/m2.
* Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.

Exclusion Criteria

* Subjects with eating disorders.
* BMI less than 25 Kg/m2.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Pregnant woman.
* Participants with an active daily exercise activity.
* Subjects whose condition makes them ineligible for the study at the investigator's discretion.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Desirée Victoria Montesinos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCAM San Antonio Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CE012309

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mental Balance Study
NCT05757050 COMPLETED NA