NCT03423719

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Fytexia · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiit-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_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2018-02-06
• Last updated: 2018-02-06

Locations

1 site across 1 country: Spain