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CompletedNCT03823196Updated Nov 1, 2019

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

An interventional study of Verum900 and Verum1800 in Overweight, sponsored by Fytexia. Completed at 1 site in Spain. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by Fytexia · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Overweight

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 20 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Fytexia is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Verum900

    The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks

    Dietary Supplement: Verum900

  • Experimental
    Verum1800

    The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks

    Dietary Supplement: Verum1800

Interventions

  • Dietary supplementVerum900

    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

    Also known as: Sinetrol® Xpur

  • Dietary supplementVerum1800

    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

    Also known as: Sinetrol® Xpur

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What researchers measure

Primary outcomes

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

    Time frame: Week 1 and Week 16

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

    Time frame: Week 1 and Week 16

Secondary outcomes

  1. Change in fecal microbiota composition

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

  2. Change in blood microbiota composition

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

  3. Change in adipose tissue microbiota composition

    Time frame: Week 1 and Week 16

  4. Change in adipose tissue lipolysis assessed with glycerol concentration

    Time frame: Week 1 and Week 16

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

    Time frame: Week 1 and Week 16

  6. Change in adipocytes diameters in adipose tissue

    Time frame: Week 1 and Week 16

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

    Time frame: Week 1 and Week 16

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

    Time frame: Week 1 and Week 16

  9. Change in total fat mass assessed by DXA

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

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

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

  11. Change in abdominal fat mass assessed by MRI

    Time frame: Week 1 and Week 16

  12. Change in abdominal subcutaneous fat mass assessed by MRI

    Time frame: Week 1 and Week 16

  13. Change in abdominal visceral fat mass assessed by MRI

    Time frame: Week 1 and Week 16

  14. Change in energy expenditure assessed by indirect calorimetry

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

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

    Time frame: Week 1 and Week 16

  16. Change in safety variables assessed by heart rate variation

    Time frame: Week 1 and Week 16

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Study locations

1 site
  • UCAM
    Murcia, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03823196
Lead sponsor
Fytexia
Responsible party
Sponsor
First posted
Jan 30, 2019
Start date
Mar 8, 2019
Primary completion
Jul 31, 2019
Completion
Oct 31, 2019
Last update
Nov 1, 2019

Study contacts

Pedro E Alcaraz Ramon
principal investigator · UCAM

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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