Change in Total Body Fat Mass Percentage Loss Versus Body WeightNCT04149158
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
A study testing Sinetrol® Xpur in people with Change in Total Body Fat Mass Percentage Loss Versus Body Weight, run by Fytexia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Change in Total Body Fat Mass Percentage Loss Versus Body Weight
- What is being tested?
- Sinetrol® Xpur
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight or obese (25 kg.m-2<BMI<42.5kg.m-2)
- healthy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Placebo, Sinetrol® Xpur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Sinetrol® XpurDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Verum | Experimental | Sinetrol® Xpur Receives: Dietary Supplement: Sinetrol® Xpur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body fat percentage loss versus bodyweight
Measured: week1; week16; week20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Change in Total Body Fat Mass Percentage Loss Versus Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz Ramon, Principal investigator, UCAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149158
- Sponsor's protocol ID
- SNTCT2015
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41399165
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT04149158
- Acronym / sponsor ID
- SNTCT2015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Verum | Experimental | Dietary Supplement: Sinetrol® XpurSinetrol® Xpur |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- overweight or obese (25 kg.m-2<BMI<42.5kg.m-2)
- healthy
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| Sinetrol® Xpur | Dietary supplement | Verum |
Primary outcome
Change in total body fat percentage loss versus bodyweight
Time frame: week1; week16; week20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Derived from this study: PubMed 41399165Muralidharan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Alcaraz Ramon principal investigator
UCAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinetrol® Xpur in people with Change in Total Body Fat Mass Percentage Loss Versus Body Weight, run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total body fat percentage loss versus bodyweight (time frame: week1; week16; week20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.