NCT04149158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

October 31, 2019

Last Update Submit

October 31, 2019

Conditions

Change in Total Body Fat Mass Percentage Loss Versus Body Weight

Outcome Measures

Primary Outcomes (1)

  • Change in total body fat percentage loss versus bodyweight

    week1; week16; week20

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Verum

EXPERIMENTAL

Sinetrol® Xpur

Dietary Supplement: Sinetrol® Xpur

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo
Sinetrol® XpurDIETARY_SUPPLEMENT
Verum

Eligibility Criteria

Age25 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsstratification of sex (40%minimum and 60% maximum of each sex)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM

Murcia, Spain

Location

Related Publications (1)

  • Muralidharan J, Romain C, Martinez-Noguera FJ, Marin-Cascales E, Chung L, Alcaraz P, Cases J. A 16-week supplementation with a polyphenol-rich supplement, Sinetrol(R) Xpur, aids in fat loss of overweight and obese volunteers: a randomised, double-blind, parallel trial. Int J Food Sci Nutr. 2026 Feb;77(1):40-47. doi: 10.1080/09637486.2025.2589845. Epub 2025 Dec 15.

    PMID: 41399165DERIVED

Study Officials

  • Pedro Alcaraz Ramon

    UCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

ES(1)