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Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®

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ClinicalTrials.gov Identifier: NCT03432104
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Fytexia

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.

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Supplement: Oxxynea® Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 23, 2018
Actual Primary Completion Date : March 7, 2018
Actual Study Completion Date : March 7, 2018

Arm Intervention/treatment
Experimental: Verum
This arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts
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.

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. Feeling active, vital, alert, or wide awake
    2. Functioning at high levels, but not at peak; able to concentrate
    3. Awake, but relaxed; responsive but not fully alert
    4. Somewhat foggy, let down
    5. Foggy; losing interest in remaining awake; slowed down
    6. Sleepy, woozy, fighting sleep; prefer to lie down
    7. No longer fighting sleep, sleep onset soon; having dream-like thoughts



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432104


Locations
Spain
UCAM (Universidad Catolica San Antonio de Murcia)
Murcia, Spain
Sponsors and Collaborators
Fytexia
Investigators
Principal Investigator: Pedro E Alcaraz Ramon UCAM (Universidad Catolica San Antonio de Murcia)

Responsible Party: Fytexia
ClinicalTrials.gov Identifier: NCT03432104     History of Changes
Other Study ID Numbers: OXCT2018
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No