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

Primary Purpose

Overweight

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Consumption of dietary supplement.
Consumption of control product
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCAM San Antonio Catholic University of MurciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Consumption of dietary supplement capsules for 6 months.

Identically appearing placebo capsules consumed for 6 months.

Outcomes

Primary Outcome Measures

Evaluation of weight loss
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.

Secondary Outcome Measures

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.
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.
Depression
Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.
Stress
Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).
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.
Dietary intake
Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).

Full Information

First Posted
February 20, 2023
Last Updated
March 9, 2023
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT05758363
Brief Title
Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Official Title
Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Consumption of dietary supplement capsules for 6 months.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Identically appearing placebo capsules consumed for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Consumption of dietary supplement.
Intervention Description
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
Other
Intervention Name(s)
Consumption of control product
Intervention Description
Consumption of 1 capsule per day of control product of identical appearance with breakfast.
Primary Outcome Measure Information:
Title
Evaluation of weight loss
Description
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.
Time Frame
From baseline to 6 months later
Secondary Outcome Measure Information:
Title
Quality of life by WHOQOL-BREF
Description
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.
Time Frame
From baseline to 6 months later
Title
Quality of life by SF-36
Description
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.
Time Frame
From baseline to 6 months later
Title
Depression
Description
Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.
Time Frame
From baseline to 6 months later
Title
Stress
Description
Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).
Time Frame
From baseline to 6 months later
Title
Anxiety
Description
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.
Time Frame
From baseline to 6 months later
Title
Dietary intake
Description
Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
Time Frame
From baseline to 6 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Desirée Victoria Montesinos
Phone
(+34) 968 27 85 523
Email
dvictoria@ucam.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catholic University of Murcia UCAM
Phone
(+34) 968 27 88 00
Email
info@ucam.edu
Facility Information:
Facility Name
UCAM San Antonio Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
San Antonio Catholic University of Murcia UCAM
Phone
(+34) 968 27 88 00

12. IPD Sharing Statement

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

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