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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Consumption of dietary supplement capsules for 6 months. |
|
| Control Group | Placebo Comparator | Identically appearing placebo capsules consumed for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumption of dietary supplement. | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM San Antonio Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Consumption of control product | Other | Consumption of 1 capsule per day of control product of identical appearance with breakfast. |
|
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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015340 |
| Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |