Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects

Fytexia

Status: Completed

Conditions: Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Sinetrol® Xpur

Study type: Interventional

Funder types: Industry

Identifiers

NCT04149158

SNTCT2015

Details and patient eligibility

About

This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.

Enrollment: 77 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• overweight or obese (25 kg.m-2<BMI<42.5kg.m-2)
• healthy

Exclusion criteria

• metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression)
• food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana)
• involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery
• start or quit smoking, high alcohol consumption
• pregnant, breastfeeding, wanting to have a baby,
• menopausal women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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77 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Verum

Experimental group

Description:

Sinetrol® Xpur

Treatment:

Dietary Supplement: Sinetrol® Xpur