Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03423719
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2018-01-30
Brief Title:
Evaluation of Fiit-ns in Health-related Quality of Life Improvement in Overweight and Obese Subjects
Sponsor:
Fytexia
Organization:
Fytexia
Study Overview
Official Title:
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
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None