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OverweightNCT03823196

Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient

A study testing Verum900 and Verum1800 in people with Overweight, run by Fytexia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to investigate the metabolization and the bioavailability of bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long chronical supplementation. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight
What is being tested?
Verum900 and Verum1800
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
8 Mar 2019to 31 Oct 2019
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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male and female with 30% min. and 70% max. of each sex, aged range: 20-50 years old
  • Overweight BMI range (27-30)
  • Having a total fat mass (BIA assessment) ≥ 25% for men and ≥ 32% for women
  • In good general health as evidenced by medical history
  • Ability to take oral medication and be willing to adhere to the regimen
  • Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Who cannot join

  • Metabolic/Chronic disorders or any kind of disease
  • Current use of any medication or food supplement
  • Have in the past been in long-term antibiotherapy (1 month or more) and/or a regular antiobiotherapy in the past 12 months
  • Former obese with a history of yoyo-effect
  • Have been involved in a weight loss program in the past 12 months or subjected to a weight reduction surgery
  • Pregnancy or lactation, or women wanting to have a baby
Show all 10Show fewer
  • Menopausal women
  • Known allergic reactions to components of the supplement, i.e., orange, grapefruit, guarana and/or caffeine
  • Having started or quit smoking
  • Having a high alcohol consumption

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • UCAM

    Murcia

Other trials in Spain

About this study

Official title: Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient: an Open-label Study on Overweight Volunteers During a Chronical Supplementation and a Post-supplementation Follow-up

The purpose of the study is to investigate the metabolization and the bioavailability of bioactive compounds from Sinetrol® Xpur, a polyphenol-rich ingredient, during a 16-week long chronical supplementation. It will be investigated the mechanism of action in adipocyte cells to try to explain the beneficial effects of the ingredient on body composition, especially on both abdominal subcutaneous and visceral fat mass.

Conditions
Overweight
Being tested
Verum900, Verum1800
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Verum900Dietary supplement

    Also called Sinetrol® Xpur

    Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks

  • Verum1800Dietary supplement

    Also called Sinetrol® Xpur

    Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks

Study groups in NCT03823196
Study groupRoleWhat they receive
Verum900ExperimentalThe arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Receives: Dietary Supplement: Verum900
Verum1800ExperimentalThe arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Receives: Dietary Supplement: Verum1800

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient

    Measured: Week 1 and Week 16

  2. Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient

    Measured: Week 1 and Week 16

Secondary outcomes (16)

  1. Change in fecal microbiota composition

    Measured: Week 1, Week 8, Week 16 and Week 20 (follow-up)

  2. Change in blood microbiota composition

    Measured: Week 1, Week 8, Week 16 and Week 20 (follow-up)

  3. Change in adipose tissue microbiota composition

    Measured: Week 1 and Week 16

  4. Change in adipose tissue lipolysis assessed with glycerol concentration

    Measured: Week 1 and Week 16

  5. Change in adipose tissue lipolysis assessed with free fatty acids concentration

    Measured: Week 1 and Week 16

  6. Change in adipocytes diameters in adipose tissue

    Measured: Week 1 and Week 16

  7. Change in adipose tissue secretion profile assessed by leptin concentration

    Measured: Week 1 and Week 16

  8. Change in adipose tissue secretion profile assessed by adiponectin concentration

    Measured: Week 1 and Week 16

  9. Change in total fat mass assessed by DXA

    Measured: Week 1, Week 16 and Week 20 (follow-up)

  10. Change in total fat-free mass assessed by DXA

    Measured: Week 1, Week 16 and Week 20 (follow-up)

  11. Change in abdominal fat mass assessed by MRI

    Measured: Week 1 and Week 16

  12. Change in abdominal subcutaneous fat mass assessed by MRI

    Measured: Week 1 and Week 16

  13. Change in abdominal visceral fat mass assessed by MRI

    Measured: Week 1 and Week 16

  14. Change in energy expenditure assessed by indirect calorimetry

    Measured: Week 1, Week 16 and Week 20 (follow-up)

  15. Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)

    Measured: Week 1 and Week 16

  16. Change in safety variables assessed by heart rate variation

    Measured: Week 1 and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start8 Mar 2019
  3. Primary completion31 Jul 2019
  4. Study completion31 Oct 2019

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823196
Sponsor's protocol ID
SNTOL2019
Status last verified
Oct 2019
First submitted
23 Jan 2019
Last updated
1 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Muralidharan J, Romain C, Chung L, Alcaraz P, Martinez-Noguera FJ, Keophiphath M, Lelouvier B, Ancel P, Gaborit B, Cases J. Effect of Sinetrol(R) Xpur on metabolic health and adiposity by interactions with gut microbiota: a randomized, open label, dose-response clinical trial. Nutr Metab (Lond). 2024 Oct 16;21(1):83. doi: 10.1186/s12986-024-00851-7.

    PubMed 39415279

  • Muralidharan J, Romain C, Bresciani L, Mena P, Angelino D, Del Rio D, Chung LH, Alcaraz PE, Cases J. Nutrikinetics and urinary excretion of phenolic compounds after a 16-week supplementation with a flavanone-rich ingredient. Food Funct. 2023 Nov 27;14(23):10506-10519. doi: 10.1039/d3fo02820h.

    PubMed 37943075

Questions about this trial

What is this clinical trial studying?

A study testing Verum900 and Verum1800 in people with Overweight, 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 8 inclusion and 10 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 1 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. 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 urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient (time frame: Week 1 and Week 16). The study lists 2 primary outcomes in all. 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 NCT03823196, which also lists 2 linked publications.

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 1 Nov 2019.

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