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

NCT ID: NCT04149158

Last Updated: 2019-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Verum

Sinetrol® Xpur

Group Type EXPERIMENTAL

Sinetrol® Xpur

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type DIETARY_SUPPLEMENT

Sinetrol® Xpur

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fytexia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Alcaraz Ramon

Role: PRINCIPAL_INVESTIGATOR

UCAM

Locations

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UCAM

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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SNTCT2015

Identifier Type: -

Identifier Source: org_study_id

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