Status:
COMPLETED
Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient
Lead Sponsor:
Fytexia
Conditions:
Overweight
Eligibility:
All Genders
20-50 years
Phase:
NA
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 suppleme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03823196
Start Date
March 8 2019
End Date
October 31 2019
Last Update
November 1 2019
Active Locations (1)
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1
UCAM
Murcia, Spain