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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-08

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum900

The arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks

Group Type EXPERIMENTAL

Verum900

Intervention Type DIETARY_SUPPLEMENT

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

The arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks

Group Type EXPERIMENTAL

Verum1800

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Sinetrol® Xpur Sinetrol® Xpur

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes