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

Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Consumption of dietary supplement.; Other: Consumption of control product

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Desirée Victoria Montesinos; Phone Number: (+34) 968 27 85 523; Email: dvictoria@ucam.edu
• Study Contact Backup: Name: Catholic University of Murcia UCAM; Phone Number: (+34) 968 27 88 00; Email: info@ucam.edu

Study Locations

• Spain
  • Murcia, Spain, 30107
    • UCAM San Antonio Catholic University of Murcia
    • Contact: San Antonio Catholic University of Murcia UCAM; Phone Number: (+34) 968 27 88 00

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Consumption of dietary supplement capsules for 6 months.	Dietary supplement: 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.
Placebo Comparator: Control Group; Identically appearing placebo capsules consumed for 6 months.	Other: Consumption of control product; Consumption of 1 capsule per day of control product of identical appearance with breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of weight loss	Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.	From baseline to 6 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life by WHOQOL-BREF	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.	From baseline to 6 months later
Quality of life by SF-36	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.	From baseline to 6 months later
Depression	Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.	From baseline to 6 months later
Stress	Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).	From baseline to 6 months later
Anxiety	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.	From baseline to 6 months later
Dietary intake	Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).	From baseline to 6 months later

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: CE012309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No