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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Verum900
Verum1800
Sponsored by
Fytexia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Verum900

Verum1800

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient
Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient

Secondary Outcome Measures

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

Full Information

First Posted
January 23, 2019
Last Updated
October 31, 2019
Sponsor
Fytexia
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1. Study Identification

Unique Protocol Identification Number
NCT03823196
Brief Title
Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum900
Arm Type
Experimental
Arm Description
The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Arm Title
Verum1800
Arm Type
Experimental
Arm Description
The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum900
Other Intervention Name(s)
Sinetrol® Xpur
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum1800
Other Intervention Name(s)
Sinetrol® Xpur
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient
Time Frame
Week 1 and Week 16
Title
Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient
Time Frame
Week 1 and Week 16
Secondary Outcome Measure Information:
Title
Change in fecal microbiota composition
Time Frame
Week 1, Week 8, Week 16 and Week 20 (follow-up)
Title
Change in blood microbiota composition
Time Frame
Week 1, Week 8, Week 16 and Week 20 (follow-up)
Title
Change in adipose tissue microbiota composition
Time Frame
Week 1 and Week 16
Title
Change in adipose tissue lipolysis assessed with glycerol concentration
Time Frame
Week 1 and Week 16
Title
Change in adipose tissue lipolysis assessed with free fatty acids concentration
Time Frame
Week 1 and Week 16
Title
Change in adipocytes diameters in adipose tissue
Time Frame
Week 1 and Week 16
Title
Change in adipose tissue secretion profile assessed by leptin concentration
Time Frame
Week 1 and Week 16
Title
Change in adipose tissue secretion profile assessed by adiponectin concentration
Time Frame
Week 1 and Week 16
Title
Change in total fat mass assessed by DXA
Time Frame
Week 1, Week 16 and Week 20 (follow-up)
Title
Change in total fat-free mass assessed by DXA
Time Frame
Week 1, Week 16 and Week 20 (follow-up)
Title
Change in abdominal fat mass assessed by MRI
Time Frame
Week 1 and Week 16
Title
Change in abdominal subcutaneous fat mass assessed by MRI
Time Frame
Week 1 and Week 16
Title
Change in abdominal visceral fat mass assessed by MRI
Time Frame
Week 1 and Week 16
Title
Change in energy expenditure assessed by indirect calorimetry
Time Frame
Week 1, Week 16 and Week 20 (follow-up)
Title
Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)
Time Frame
Week 1 and Week 16
Title
Change in safety variables assessed by heart rate variation
Time Frame
Week 1 and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro E Alcaraz Ramon
Organizational Affiliation
UCAM
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM
City
Murcia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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