Trial | NCT03423719  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Fiit-ns® ...

  • Study Participants

    92
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 Started
Apr 30
2015
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2017
Last Update
Feb 06
2018

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.

Verum Experimental

This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks.

Placebo Placebo Comparator

This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks.

Criteria 

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
No Results Posted