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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423719
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Fytexia

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).

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: Fiit-ns® Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Change in body weight [ Time Frame: Baseline (Week 1) and end of the supplementation period (Week 16) ]
    Change in body weight is measured with calibrated weighing scales

  2. Change in waist circumference [ Time Frame: Baseline (Week 1) and end of the supplementation period (Week 16) ]
    Change is waist circumference is measured with a non-stretchable tape and used to calculate change in Index of Central Obesity (ICO)

  3. Change in total body fat mass [ Time Frame: Baseline (Week 1) and end of the supplementation period (Week 16) ]
    Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

  4. Change in trunk fat mass [ Time Frame: Baseline (Week 1) and end of the supplementation period (Week 16 ) ]
    Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan

  5. Change in physical activity level [ Time Frame: Baseline (Week 1) and end of the supplementation period (Week 16) ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423719


Locations
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Spain
UCAM (Universidad Catolica San Antonio de Murcia)
Murcia, Spain
Sponsors and Collaborators
Fytexia
Investigators
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Principal Investigator: Pedro E Alcaraz Ramon UCAM (Universidad Catolica San Antonio de Murcia)
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Responsible Party: Fytexia
ClinicalTrials.gov Identifier: NCT03423719    
Other Study ID Numbers: FITCT2015
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight