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The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks. |
|
| Placebo | Placebo Comparator | This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiit-ns® | Dietary Supplement | Fiit-ns® is a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot. It also provides Vitamin B3. Daily dosage is 900 mg in two 450 mg-capsules for 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life as assessed by the SF-36 Health Survey | Baseline (Week 1) and end of the supplementation period (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Change in body weight is measured with calibrated weighing scales | Baseline (Week 1) and end of the supplementation period (Week 16) |
| Change in waist circumference | Change is waist circumference is measured with a non-stretchable tape and used to calculate change in Index of Central Obesity (ICO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro E Alcaraz Ramon | UCAM (Universidad Catolica San Antonio de Murcia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCAM (Universidad Catolica San Antonio de Murcia) | Murcia | Spain |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Placebo product is 100% maltodextrin. Daily dosage is 900 mg in two 450 mg-capsules of identical appearance than the supplement capsule for 16 weeks. |
|
| Baseline (Week 1) and end of the supplementation period (Week 16) |
| Change in total body fat mass | Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan | Baseline (Week 1) and end of the supplementation period (Week 16) |
| Change in trunk fat mass | Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan | Baseline (Week 1) and end of the supplementation period (Week 16 ) |
| Change in physical activity level | Physical activity is assessed with International Physical Activity Questionnaire (IPAQ) IPAQ consists in 27 items that cover 4 different domains of physical activity (working, transportation, housework and gardening & leisure-time) in terms of time spent during the 7 previous days. Total score is the sum of the 4 domains and results are presented as an estimation of energy expenditure in metabolic equivalent-minutes per week (Met-min/week). | Baseline (Week 1) and end of the supplementation period (Week 16) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |