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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03432104
Other study ID # OXCT2018
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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