Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

Fytexia

Status: Completed

Conditions: Dietary Modification

Treatments: Dietary Supplement: Oxxynea®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03432104

OXCT2018

Details and patient eligibility

About

The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In good general health
• Agreement to adhere to diet considerations

Exclusion criteria

• Smoking
• Pregnancy / Lactation
• Current use of any medication or food supplement
• Known allergic reaction to components of the supplement/placebo

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Verum

Experimental group

Description:

This arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Oxxynea®

Placebo

Placebo Comparator group

Description:

This arms receives 1 x 450 mg-capsule of Placebo, containing maltodextrin only

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Oxxynea®