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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423719
• Other study ID #: FITCT2015
• Status: Completed
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 5, 2018
• Start date: April 2015
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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
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.

Locations

Country	Name	City	State
Spain	UCAM (Universidad Catolica San Antonio de Murcia)	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in body weight	Change in body weight is measured with calibrated weighing scales	Baseline (Week 1) and end of the supplementation period (Week 16)
Secondary	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)	Baseline (Week 1) and end of the supplementation period (Week 16)
Secondary	Change in total body fat mass	Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan	Baseline (Week 1) and end of the supplementation period (Week 16)
Secondary	Change in trunk fat mass	Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan	Baseline (Week 1) and end of the supplementation period (Week 16 )
Secondary	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).	Baseline (Week 1) and end of the supplementation period (Week 16)