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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

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

Group Type EXPERIMENTAL

Fiit-ns®

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes