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

Fytexia

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Fiit-ns®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03423719

FITCT2015

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

92 participants in 2 patient groups, including a placebo group

Verum

Experimental group

Description:

This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks.

Treatment:

Dietary Supplement: Fiit-ns®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo