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Completed

NCT Number: NCT03423719

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

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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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 6, 2018
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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