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

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Verum900; Dietary supplement: Verum1800

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • UCAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient	Week 1 and Week 16
Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient	Week 1 and Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fecal microbiota composition	Week 1, Week 8, Week 16 and Week 20 (follow-up)
Change in blood microbiota composition	Week 1, Week 8, Week 16 and Week 20 (follow-up)
Change in adipose tissue microbiota composition	Week 1 and Week 16
Change in adipose tissue lipolysis assessed with glycerol concentration	Week 1 and Week 16
Change in adipose tissue lipolysis assessed with free fatty acids concentration	Week 1 and Week 16
Change in adipocytes diameters in adipose tissue	Week 1 and Week 16
Change in adipose tissue secretion profile assessed by leptin concentration	Week 1 and Week 16
Change in adipose tissue secretion profile assessed by adiponectin concentration	Week 1 and Week 16
Change in total fat mass assessed by DXA	Week 1, Week 16 and Week 20 (follow-up)
Change in total fat-free mass assessed by DXA	Week 1, Week 16 and Week 20 (follow-up)
Change in abdominal fat mass assessed by MRI	Week 1 and Week 16
Change in abdominal subcutaneous fat mass assessed by MRI	Week 1 and Week 16
Change in abdominal visceral fat mass assessed by MRI	Week 1 and Week 16
Change in energy expenditure assessed by indirect calorimetry	Week 1, Week 16 and Week 20 (follow-up)
Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)	Week 1 and Week 16
Change in safety variables assessed by heart rate variation	Week 1 and Week 16

Collaborators and Investigators

• Sponsor: Fytexia
• Investigators: Principal Investigator: Pedro E Alcaraz Ramon, UCAM

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: SNTOL2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No