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

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823196
• Other study ID #: SNTOL2019
• Status: Completed
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2019
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	UCAM	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient		Week 1 and Week 16
Primary	Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient		Week 1 and Week 16
Secondary	Change in fecal microbiota composition		Week 1, Week 8, Week 16 and Week 20 (follow-up)
Secondary	Change in blood microbiota composition		Week 1, Week 8, Week 16 and Week 20 (follow-up)
Secondary	Change in adipose tissue microbiota composition		Week 1 and Week 16
Secondary	Change in adipose tissue lipolysis assessed with glycerol concentration		Week 1 and Week 16
Secondary	Change in adipose tissue lipolysis assessed with free fatty acids concentration		Week 1 and Week 16
Secondary	Change in adipocytes diameters in adipose tissue		Week 1 and Week 16
Secondary	Change in adipose tissue secretion profile assessed by leptin concentration		Week 1 and Week 16
Secondary	Change in adipose tissue secretion profile assessed by adiponectin concentration		Week 1 and Week 16
Secondary	Change in total fat mass assessed by DXA		Week 1, Week 16 and Week 20 (follow-up)
Secondary	Change in total fat-free mass assessed by DXA		Week 1, Week 16 and Week 20 (follow-up)
Secondary	Change in abdominal fat mass assessed by MRI		Week 1 and Week 16
Secondary	Change in abdominal subcutaneous fat mass assessed by MRI		Week 1 and Week 16
Secondary	Change in abdominal visceral fat mass assessed by MRI		Week 1 and Week 16
Secondary	Change in energy expenditure assessed by indirect calorimetry		Week 1, Week 16 and Week 20 (follow-up)
Secondary	Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)		Week 1 and Week 16
Secondary	Change in safety variables assessed by heart rate variation		Week 1 and Week 16