An interventional study of Fiit-ns® and Placebo in Overweight and Obesity, sponsored by Fytexia. Completed at 1 site in Spain. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Fytexia · Not applicable, Interventional, and Supportive care
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).
Exclusion Criteria:
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®
This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks.
Dietary Supplement: Placebo
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.
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)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fytexia