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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Other: Consumption of control product; Dietary Supplement: Consumption of dietary supplement.

• Registration Number: NCT05758363
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-07
• Study Start: 2023-03-09
• Primary Completion: 2023-09-30
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Consumption of control product	Identically appearing placebo capsules consumed for 6 months.
Experimental Group	Consumption of dietary supplement.	Consumption of dietary supplement capsules for 6 months.

Primary Outcome Measures

Name	Time	Method
Evaluation of weight loss	From baseline to 6 months later	Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.

Secondary Outcome Measures

Name	Time	Method
Dietary intake	From baseline to 6 months later	Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
Quality of life by WHOQOL-BREF	From baseline to 6 months later	World Health Organization Quality of Life Brief version test. The raw scores are transformed into a normalized scale ranging from 4 to 20 and from 0 to 100. Higher scores indicating better quality of life.
Quality of life by SF-36	From baseline to 6 months later	Short Form 36 Health Survey Questionnaire (SF-36). The SF-36 contains 36 items that measure eight dimensions or scales. The scores for each dimension will be calculated in both raw and transformed form as indicated in the manual, with higher scores indicating better health status for that particular dimension.
Depression	From baseline to 6 months later	Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.
Anxiety	From baseline to 6 months later	State-Trait Anxiety Inventory (STAI) Test. Scores can vary between 0 to a maximum of 60. Higher scores correlate positively with higher levels of anxiety.
Stress	From baseline to 6 months later	Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).

Trial Locations

Locations (1)

UCAM San Antonio Catholic University of Murcia; 🇪🇸 Murcia, Spain