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

Primary Purpose

Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Sinetrol® Xpur
Sponsored by
Fytexia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • UCAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Verum

Arm Description

Sinetrol® Xpur

Outcomes

Primary Outcome Measures

Change in total body fat percentage loss versus bodyweight

Secondary Outcome Measures

Full Information

First Posted
October 31, 2019
Last Updated
October 31, 2019
Sponsor
Fytexia
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1. Study Identification

Unique Protocol Identification Number
NCT04149158
Brief Title
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Change in Total Body Fat Mass Percentage Loss Versus Body Weight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Verum
Arm Type
Experimental
Arm Description
Sinetrol® Xpur
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Sinetrol® Xpur
Primary Outcome Measure Information:
Title
Change in total body fat percentage loss versus bodyweight
Time Frame
week1; week16; week20

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
stratification of sex (40%minimum and 60% maximum of each sex)
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Alcaraz Ramon
Organizational Affiliation
UCAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM
City
Murcia
Country
Spain

12. IPD Sharing Statement

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

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