Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

NCT03432104 | Completed

• 1 other identifier: OXCT2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in urine phenolic metabolites excretion after acute ingestion of the supplement/placebo

  Baseline (12h pre-ingestion), 0-3h, 3-6h, 6-10h, 10-14h, 14-24h, 24-32h, 32-48h post-ingestion

• Change in total circulating antioxidant defences after acute ingestion of the supplement/placebo

  0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion

• Change in post-prandial glycemia

  0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion

• Change in post-prandial insulinemia

  0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion

• Change in sleepiness during the day

  0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion

Study Arms (2)

Verum

EXPERIMENTAL

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

Dietary Supplement: Oxxynea®; Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Oxxynea®; Dietary Supplement: Placebo

Interventions

Oxxynea® DIETARY_SUPPLEMENT

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; Verum

Placebo DIETARY_SUPPLEMENT

Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.

Placebo; Verum

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fytexia: lead

Study Sites (1)

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Location

MeSH Terms

Interventions

Oxxynea

Study Officials

• Pedro E Alcaraz Ramon

  UCAM (Universidad Catolica San Antonio de Murcia)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 14, 2018
• Study Start: February 23, 2018
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

ES (1)