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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Fiit-ns®; Dietary Supplement: Placebo

• Registration Number: NCT03423719
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-06
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Fiit-ns®	This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks.
Placebo	Placebo	This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in waist circumference	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)
Change in total body fat mass	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
Change in body weight	Baseline (Week 1) and end of the supplementation period (Week 16)	Change in body weight is measured with calibrated weighing scales
Change in physical activity level	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).
Change in trunk fat mass	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

Trial Locations

Locations (1)

UCAM (Universidad Catolica San Antonio de Murcia); 🇪🇸 Murcia, Spain