Clinical trial NCT03823196: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in urine polyphenol metabolites excretion after acute and chronic ingestion of the ingredient
timeFrame: Week 1 and Week 16
measure: Change in plasma polyphenol metabolites concentration after acute and chronic ingestion of the ingredient
timeFrame: Week 1 and Week 16
Secondary outcomes:
measure: Change in fecal microbiota composition
timeFrame: Week 1, Week 8, Week 16 and Week 20 (follow-up)
measure: Change in blood microbiota composition
timeFrame: Week 1, Week 8, Week 16 and Week 20 (follow-up)
measure: Change in adipose tissue microbiota composition
timeFrame: Week 1 and Week 16
measure: Change in adipose tissue lipolysis assessed with glycerol concentration
timeFrame: Week 1 and Week 16
measure: Change in adipose tissue lipolysis assessed with free fatty acids concentration
timeFrame: Week 1 and Week 16
measure: Change in adipocytes diameters in adipose tissue
timeFrame: Week 1 and Week 16
measure: Change in adipose tissue secretion profile assessed by leptin concentration
timeFrame: Week 1 and Week 16
measure: Change in adipose tissue secretion profile assessed by adiponectin concentration
timeFrame: Week 1 and Week 16
measure: Change in total fat mass assessed by DXA
timeFrame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in total fat-free mass assessed by DXA
timeFrame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in abdominal fat mass assessed by MRI
timeFrame: Week 1 and Week 16
measure: Change in abdominal subcutaneous fat mass assessed by MRI
timeFrame: Week 1 and Week 16
measure: Change in abdominal visceral fat mass assessed by MRI
timeFrame: Week 1 and Week 16
measure: Change in energy expenditure assessed by indirect calorimetry
timeFrame: Week 1, Week 16 and Week 20 (follow-up)
measure: Change in safety variables assessed by blood pressure variation (systole and diastole in mmHg)
timeFrame: Week 1 and Week 16
measure: Change in safety variables assessed by heart rate variation
timeFrame: Week 1 and Week 16
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM
Study officials:
affiliation: UCAM
name: Pedro E Alcaraz Ramon
role: PRINCIPAL_INVESTIGATOR
References: