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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05758363
• Other study ID #: CE012309
• Status: Completed
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Weight Loss

Intervention

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.

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

Locations

Country	Name	City	State
Spain	UCAM San Antonio Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dietary intake	Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).	From baseline to 6 months later