Dietary ModificationNCT03432104
Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®
A study testing Oxxynea® in people with Dietary Modification, run by Fytexia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Oxxynea®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2018to 7 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health
- Agreement to adhere to diet considerations
Who cannot join
- Smoking
- Pregnancy / Lactation
- Current use of any medication or food supplement
- Known allergic reaction to components of the supplement/placebo
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Oxxynea®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | This arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts Receives: Dietary Supplement: Oxxynea®; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | This arms receives 1 x 450 mg-capsule of Placebo, containing maltodextrin only Receives: Dietary Supplement: Oxxynea®; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion
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.
Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
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.
Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
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
Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Feb 2018
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro E Alcaraz Ramon, Principal investigator, UCAM (Universidad Catolica San Antonio de Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432104
- Sponsor's protocol ID
- OXCT2018
- Status last verified
- Mar 2018
- First submitted
- 7 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03432104
- Acronym / sponsor ID
- OXCT2018
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: Oxxynea®, Dietary Supplement: PlaceboThis arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts |
| Placebo | Placebo comparator | Dietary Supplement: Oxxynea®, Dietary Supplement: PlaceboThis arms receives 1 x 450 mg-capsule of Placebo, containing maltodextrin only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- In good general health
- Agreement to adhere to diet considerations
Key exclusion criteria (4 listed)
- Smoking
- Pregnancy / Lactation
- Current use of any medication or food supplement
- Known allergic reaction to components of the supplement/placebo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, Verum |
| PlaceboPlacebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule. | Dietary supplement | Placebo, Verum |
Primary outcome
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.
5 secondary outcomes
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
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
Change in post-prandial glycemia
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
Change in post-prandial insulinemia
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
Change in sleepiness during the day
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro E Alcaraz Ramon principal investigator
UCAM (Universidad Catolica San Antonio de Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxxynea® in people with Dietary Modification, run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.