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

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Fiit-ns®

Placebo

About this trial

This is an interventional supportive care trial for Overweight and Obesity

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UCAM (Universidad Catolica San Antonio de Murcia)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in health-related quality of life as assessed by the SF-36 Health Survey

Secondary Outcome Measures

Change in body weight

Change in body weight is measured with calibrated weighing scales

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)

Change in total body fat mass

Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

Change in trunk fat mass

Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

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).

Full Information

NCT ID

NCT03423719

First Posted

January 30, 2018

Last Updated

February 5, 2018

Sponsor

Fytexia

1. Study Identification

Unique Protocol Identification Number

NCT03423719

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fiit-ns®

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in health-related quality of life as assessed by the SF-36 Health Survey

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16)

Secondary Outcome Measure Information:

Title

Change in body weight

Description

Change in body weight is measured with calibrated weighing scales

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16)

Title

Change in waist circumference

Description

Change is waist circumference is measured with a non-stretchable tape and used to calculate change in Index of Central Obesity (ICO)

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16)

Title

Change in total body fat mass

Description

Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16)

Title

Change in trunk fat mass

Description

Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16 )

Title

Change in physical activity level

Description

Time Frame

Baseline (Week 1) and end of the supplementation period (Week 16)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro E Alcaraz Ramon

Organizational Affiliation

UCAM (Universidad Catolica San Antonio de Murcia)

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCAM (Universidad Catolica San Antonio de Murcia)

City

Murcia

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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