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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Consumption of dietary supplement.
* Other: Consumption of control product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |