Overweight and Obesity
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTFiit-ns®
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Fytexia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline (Week 1) and end of the supplementation period (Week 16) | Change in body weight is measured with calibrated weighing scales |
| Change in waist circumference | Baseline (Week 1) and end of the supplementation period (Week 16) | Change is waist circumference is measured with a non-stretchable tape and used to calculate change in Index of Central Obesity (ICO) |
| Change in total body fat mass | Baseline (Week 1) and end of the supplementation period (Week 16) | Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan |
| Change in trunk fat mass | Baseline (Week 1) and end of the supplementation period (Week 16 ) | Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan |
| Change in physical activity level | Baseline (Week 1) and end of the supplementation period (Week 16) | 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). |
Countries
Spain
Outcome results
None listed