NCT03423719

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
Last Updated

February 6, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

January 30, 2018

Last Update Submit

February 5, 2018

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in body weight

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

  • Change in waist circumference

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

  • Change in total body fat mass

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

  • Change in trunk fat mass

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

  • Change in physical activity level

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

Study Arms (2)

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.

Dietary Supplement: Fiit-ns®

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Fiit-ns®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.

Verum
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro E Alcaraz Ramon

    UCAM (Universidad Catolica San Antonio de Murcia)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 6, 2018

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-01

Locations

ES(1)