Bioavailability, Pharmacokinetic and Mechanistic Study of Sinetrol® Xpur, a Polyphenol-rich Ingredient
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedNovember 1, 2019
October 1, 2019
5 months
January 23, 2019
October 31, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (2)
Verum900
EXPERIMENTALThe arm will receive 900 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Verum1800
EXPERIMENTALThe arm will receive 1800 mg of Sinetrol® Xpur, a blend of citrus and guarana extracts, daily for 16 weeks
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fytexialead
Study Sites (1)
UCAM
Murcia, Spain
Related Publications (2)
Muralidharan J, Romain C, Chung L, Alcaraz P, Martinez-Noguera FJ, Keophiphath M, Lelouvier B, Ancel P, Gaborit B, Cases J. Effect of Sinetrol(R) Xpur on metabolic health and adiposity by interactions with gut microbiota: a randomized, open label, dose-response clinical trial. Nutr Metab (Lond). 2024 Oct 16;21(1):83. doi: 10.1186/s12986-024-00851-7.
PMID: 39415279DERIVEDMuralidharan J, Romain C, Bresciani L, Mena P, Angelino D, Del Rio D, Chung LH, Alcaraz PE, Cases J. Nutrikinetics and urinary excretion of phenolic compounds after a 16-week supplementation with a flavanone-rich ingredient. Food Funct. 2023 Nov 27;14(23):10506-10519. doi: 10.1039/d3fo02820h.
PMID: 37943075DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro E Alcaraz Ramon
UCAM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 30, 2019
Study Start
March 8, 2019
Primary Completion
July 31, 2019
Study Completion
October 31, 2019
Last Updated
November 1, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share