Biological AvailabilityBIOPTERONCT05561075
Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO)
A study testing Pterostilbene cocrystal and Pterostilbene free form in people with Biological Availability, run by Fundació Eurecat at 1 site in Spain.
Trial summary
Oxidative stress and reactive oxygen species (ROS) can seriously affect cells, tissues and organs. The human body is capable of counteracting ROS production by stimulating antioxidant defense systems and consequently adapting to the oxidative challenge. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Pterostilbene cocrystal and Pterostilbene free form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2022to 17 Nov 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years of age.
- Sign the informed consent form.
- Know how to read, write and speak Spanish
Who cannot join
- Take supplements or multivitamin supplements or phytotherapeutic products (especially infusions) that interfere with the treatment under study up to 30 days before the start of the study.
- Be lacto-vegetarian, lacto-ovo-vegetarian, or vegan.
- Present intolerances and/or food allergies related to pterostilbene.
- Be a smoker.
- Having received antibiotic treatment up to 30 days before the start of the study.
- Present values of body mass index ≤ 18kg/m^2 or ≥ 35 kg/m^2.
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- Present some chronic disease with clinical manifestations: coronary heart disease, cardiovascular disease, diabetes, celiac disease, Crohn's disease, chronic kidney disease, cancer, autoimmune diseases (such as fibromyalgia), respiratory and/or gastrointestinal diseases that may compromise the absorption of the compound.
- Clinical history of anemia.
- Being pregnant or intending to became pregnant.
- Be in breastfeeding period.
- Being unable to follow the study guidelines.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form in Healthy Volunteers. Crossover, Randomized, Double-Blind Study (BIOPTERO)
Oxidative stress and reactive oxygen species (ROS) can seriously affect cells, tissues and organs. The human body is capable of counteracting ROS production by stimulating antioxidant defense systems and consequently adapting to the oxidative challenge.
Several transcription factors are involved in the induction of antioxidant genes. Activators of nuclear factor derived from erythroid 2 (NRF2), a protein that controls the expression of certain genes, are considered agents capable of inducing antioxidant capacity and to alleviate ROS. There are some food bioactive compounds, including polyphenols, capable of activating NRF2.
Read more
Pterostilbene (PT) is a stilbenoid found in many natural sources, and is emerging as an antioxidant due to its potential preventive and therapeutic properties in a long list of diseases. Despite its apparent properties, the water solubility and bioavailability of PT are low.
The co-crystallization of nutraceuticals is a recent strategy based on crystal engineering to overcome their low solubility and, therefore, their low oral bioavailability. It has been identified and characterized a cocrystal of pterostilbene that can increase oral bioavailability in animals by up to 10 times compared to the commercial free base PT.
The main objective of the study is to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT).
The secondary objectives of the study are to determine the pharmacokinetic parameters:
- Relative oral bioavailability (Frel)
- Maximum concentration (Cmax).
- Maximum time (Tmax).
- Half life time (T1/2).
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
- Conditions
- Biological Availability
- Being tested
- Pterostilbene cocrystal, Pterostilbene free form
- Keywords
- Polyphenols, Antioxidant activity, Co-crystallization, Pterostilbene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterostilbene cocrystalDietary supplement
One capsule with Pterostilbene cocrystal
Pterostilbene free formDietary supplement
One capsule with Pterostilbene free form
| Study group | Role | What they receive |
|---|---|---|
| Pterostilbene cocrystal | Experimental | Not described Receives: Dietary Supplement: Pterostilbene cocrystal |
| Pterostilbene free form | Active comparator | Not described Receives: Dietary Supplement: Pterostilbene free form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels.
Fasting pterostilbene levels in plasma will be determined before consume the capsule with pterostilbene until 24 hours postprandially at 8 points after consuming the capsule (0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours).
Measured: At week 1 and week 2
Secondary outcomes (5)
Maximum plasma concentration (Cmax)
Maximum plasma concentration of pterostilbene
Measured: At week 1 and week 2
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of pterostilbene.
Measured: At week 1 and week 2
Half-life (T1/2).
Time taken for half the initial dose of pterostilbene administered to be eliminated from the body
Measured: At week 1 and week 2
Area Under the Curve (AUC 0-inf) of plasma pterostilbene levels.
Fasting pterostilbene levels in plasma will be determined before consume the capsule with pterostilbene until 24 hours postprandially at 8 points after consuming the capsule (0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours).
Measured: At week 1 and week 2
Relative oral bioavailability (Frel)
Fasting pterostilbene levels in plasma will be determined before consume the capsule with pterostilbene until 24 hours postprandially at 8 points after consuming the capsule (0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours).
Measured: At week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start20 Oct 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Circe, S.L.
- Responsible party
- Sponsor
- Investigators
- Antoni Caimari, PhD, Principal investigator, UTNS (Eurecat_Reus)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561075
- Sponsor's protocol ID
- BIOPTERO
- Acronym
- BIOPTERO
- Status last verified
- Mar 2023
- First submitted
- 27 Sep 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this study IPD will not be shared with other researchers because all the information will be processed by the UTNS of Eurecat.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form in Healthy Volunteers. Crossover, Randomized, Double-Blind Study (BIOPTERO)
- ClinicalTrials.gov ID
- NCT05561075
- Acronym / sponsor ID
- BIOPTERO / BIOPTERO
- Conditions
- Biological Availability
- Keywords
- Polyphenols, Antioxidant activity, Co-crystallization, Pterostilbene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Circe, S.L.
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 30 Sep 2022 (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.
Oxidative stress and reactive oxygen species (ROS) can seriously affect cells, tissues and organs. The human body is capable of counteracting ROS production by stimulating antioxidant defense systems and consequently adapting to the oxidative challenge.
Several transcription factors are involved in the induction of antioxidant genes. Activators of nuclear factor derived from erythroid 2 (NRF2), a protein that controls the expression of certain genes, are considered agents capable of inducing antioxidant capacity and to alleviate ROS. There are some food bioactive compounds, including polyphenols, capable of activating NRF2.
Pterostilbene (PT) is a stilbenoid found in many natural sources, and is emerging as an antioxidant due to its potential preventive and therapeutic properties in a long list of diseases. Despite its apparent properties, the water solubility and bioavailability of PT are low.
The co-crystallization of nutraceuticals is a recent strategy based on crystal engineering to overcome their low solubility and, therefore, their low oral bioavailability. It has been identified and characterized a cocrystal of pterostilbene that can increase oral bioavailability in animals by up to 10 times compared to the commercial free base PT.
The main objective of the study is to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT).
The secondary objectives of the study are to determine the pharmacokinetic parameters:
- Relative oral bioavailability (Frel)
- Maximum concentration (Cmax).
- Maximum time (Tmax).
- Half life time (T1/2).
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pterostilbene cocrystal | Experimental | Dietary Supplement: Pterostilbene cocrystal |
| Pterostilbene free form | Active comparator | Dietary Supplement: Pterostilbene free form |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 18 and 65 years of age.
- Sign the informed consent form.
- Know how to read, write and speak Spanish
Key exclusion criteria (12 listed)
- Take supplements or multivitamin supplements or phytotherapeutic products (especially infusions) that interfere with the treatment under study up to 30 days before the start of the study.
- Be lacto-vegetarian, lacto-ovo-vegetarian, or vegan.
- Present intolerances and/or food allergies related to pterostilbene.
- Be a smoker.
- Having received antibiotic treatment up to 30 days before the start of the study.
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 |
|---|---|---|
| Pterostilbene cocrystalOne capsule with Pterostilbene cocrystal | Dietary supplement | Pterostilbene cocrystal |
| Pterostilbene free formOne capsule with Pterostilbene free form | Dietary supplement | Pterostilbene free form |
Primary outcome
Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels.
Time frame: At week 1 and week 2
Fasting pterostilbene levels in plasma will be determined before consume the capsule with pterostilbene until 24 hours postprandially at 8 points after consuming the capsule (0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours and 24 hours).
5 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: At week 1 and week 2
Time for maximum plasma concentration (Tmax)
Time frame: At week 1 and week 2
Half-life (T1/2).
Time frame: At week 1 and week 2
Area Under the Curve (AUC 0-inf) of plasma pterostilbene levels.
Time frame: At week 1 and week 2
Relative oral bioavailability (Frel)
Time frame: At week 1 and week 2
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 16 Mar 2023.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No. In this study IPD will not be shared with other researchers because all the information will be processed by the UTNS of Eurecat.
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.
Antoni Caimari, PhD principal investigator
UTNS (Eurecat_Reus)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pterostilbene cocrystal and Pterostilbene free form in people with Biological Availability, run by Fundació Eurecat 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 3 inclusion and 12 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 16 Mar 2023. 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. 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?
Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels. (time frame: At week 1 and week 2). 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 16 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.