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Completed

NCT Number: NCT03823196

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

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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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Verum900

Dietary Supplement

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

Other names: Sinetrol® Xpur

Verum1800

Dietary Supplement

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

Other names: Sinetrol® Xpur

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

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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