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

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 Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Fiit-ns®; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • UCAM (Universidad Catolica San Antonio de Murcia)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: Placebo; This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in health-related quality of life as assessed by the SF-36 Health Survey	Baseline (Week 1) and end of the supplementation period (Week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change in body weight is measured with calibrated weighing scales	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)	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	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	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).	Baseline (Week 1) and end of the supplementation period (Week 16)

Collaborators and Investigators

• Sponsor: Fytexia
• Investigators: Principal Investigator: Pedro E Alcaraz Ramon, UCAM (Universidad Catolica San Antonio de Murcia)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: FITCT2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No