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

Study Overview
=================
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.

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

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Verum900
* Dietary Supplement: Verum1800


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum900<br>The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks | Dietary Supplement: Verum900<br>* 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<br>* Other names: Sinetrol® Xpur;|
| Experimental: Verum1800<br>The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks | Dietary Supplement: Verum1800<br>* 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<br>* Other names: Sinetrol® Xpur;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |