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

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Verum1800; Dietary Supplement: Verum900

• Registration Number: NCT03823196
• Lead Sponsor: Fytexia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2019-03-08
• Primary Completion: 2019-07-31
• Status Verified: 2019-10
• Study Completion: 2019-10-31
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum1800	Verum1800	The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Verum900	Verum900	The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in fecal microbiota composition	Week 1, Week 8, Week 16 and Week 20 (follow-up)
Change in adipose tissue lipolysis assessed with free fatty acids 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 abdominal visceral fat mass assessed by MRI	Week 1 and Week 16
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 secretion profile assessed by leptin concentration	Week 1 and Week 16
Change in safety variables assessed by heart rate variation	Week 1 and Week 16
Change in blood microbiota composition	Week 1, Week 8, Week 16 and Week 20 (follow-up)
Change in adipocytes diameters in adipose tissue	Week 1 and Week 16
Change in total fat-free mass assessed by DXA	Week 1, Week 16 and Week 20 (follow-up)
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 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

Trial Locations

Locations (1)

UCAM; 🇪🇸 Murcia, Spain