Evaluation of Fiit-ns® in Health-related Quality of Life Improvement in Overweight and Obese Subjects

Study Overview
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Brief Summary
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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).

Official Title
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Effect of a 16-week Supplementation With a Mediterranean Fruit and Vegetables Extract Rich in Polyphenols, Fiit-ns®, on Health-related Quality of Life of Overweight and Obese Volunteers: a Randomized, Double-blind, Parallel Trial

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Fiit-ns®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2 25-55 years old Exclusion Criteria: Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression) Allergy to one of the ingredients of the supplement Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program Smoking cessation High alcohol consumption Pregnancy Breastfeeding Menopausal women Involvement in physical activity more than twice a week

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks. | Dietary Supplement: Fiit-ns®<br>* 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.<br>|
| Placebo Comparator: Placebo<br>This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) |