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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
92
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.
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.
UCAM (Universidad Catolica San Antonio de Murcia)
Murcia, Spain
Change in health-related quality of life as assessed by the SF-36 Health Survey
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in body weight
Change in body weight is measured with calibrated weighing scales
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
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