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Completed

NCT Number: NCT03432104

Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

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.

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Key information

Conditions

Dietary Modification

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Change in plasma concentration of phenolic metabolites after acute ingestion of the supplement/placebo

    Time frame: 0h, 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Change in post-prandial glycemia

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

    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.

  4. Change in post-prandial insulinemia

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

    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.

  5. Change in sleepiness during the day

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

    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

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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