Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

Dietary Modification Clinical Trial

Official title:

Evaluation of Absorption and Metabolism of Phenolic Compounds From Oxxynea®, a Blend of Fruit and Vegetable Extracts, in Human Healthy Volunteers: a Randomized, Double-blind, Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432104
• Other study ID #: OXCT2018
• Status: Completed
• Phase: N/A
• First received: February 7, 2018
• Last updated: March 12, 2018
• Start date: February 23, 2018
• Est. completion date: March 7, 2018

Study information

• Verified date: March 2018
• Source: Fytexia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• Oxxynea®
Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.
• Placebo
Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.

Locations

Country	Name	City	State
Spain	UCAM (Universidad Catolica San Antonio de Murcia)	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fytexia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma concentration of phenolic metabolites after acute ingestion of the supplement/placebo	Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Plasma metabolites will be identified and quantified by HPLC-MS.	0h, 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion
Secondary	Change in urine phenolic metabolites excretion after acute ingestion of the supplement/placebo	Urine samples will be collected in baseline (12h pre-ingestion) and up to 48h according to the time frame. Urine metabolites will be identified and quantified by HPLC-MS.	Baseline (12h pre-ingestion), 0-3h, 3-6h, 6-10h, 10-14h, 14-24h, 24-32h, 32-48h post-ingestion
Secondary	Change in total circulating antioxidant defences after acute ingestion of the supplement/placebo	Red blood cell (RBCs) samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 24h according to the time frame.; RBCs will be submitted to the KRL (Kit Radicaux Libres) test which consists in inducing a free-radical attack to RBCs and to follow hemolysis. Results will be expressed as the time required to reach 50% of maximal hemolysis.	0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion
Secondary	Change in post-prandial glycemia	Glycemia will be measured in a fasted state in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 6h according to the time frame.	0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
Secondary	Change in post-prandial insulinemia	Insulinemia will be measured in a fasted state in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 6h according to the time frame.	0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
Secondary	Change in sleepiness during the day	Change in sleepiness will be assessed using the Stanford Sleepiness Scale (SSS), a 7-point self-rating scale. The scale is used to track overall alertness during the day. At each point of the time frame, volunteers will be asked to rate their feelings of sleepiness from 1 to 7 according to the following descriptors: Feeling active, vital, alert, or wide awake; Functioning at high levels, but not at peak; able to concentrate; Awake, but relaxed; responsive but not fully alert; Somewhat foggy, let down; Foggy; losing interest in remaining awake; slowed down; Sleepy, woozy, fighting sleep; prefer to lie down; No longer fighting sleep, sleep onset soon; having dream-like thoughts	0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion