Biological AvailabilityBIOPTERO2NCT06289140
Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2)
A study testing Pterostilbene cocrystal (ccPT) - Gelatin capsule, Pterostilbene free form (PT) and Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule in people with Biological Availability, run by Fundació Eurecat at 1 site in Spain.
Trial summary
The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Pterostilbene cocrystal (ccPT) - Gelatin capsule, Pterostilbene free form (PT) and Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule
- 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
- 11 Mar 2024to 7 May 2024
- 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
- Men only
- 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 or the excipients.
- 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 a New Formulation of Pterostilbene Co-crystal in Comparison With Its Free Form in Healthy Volunteers: Crossover, Randomized and Simple Blind Study (BIOPTERO2)
The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:
- Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?
Read more
Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.
Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT).
Read the detailed description
The oxidative stress (OS) is a condition where pro-oxidative processes overwhelm cellular antioxidant defenses due to disruption in redox signaling. This results in the body's inability to eliminate reactive oxygen species (ROS) or repair damages, potentially leading to severe impacts on cells, tissues, and organs.
Pterostilbene (PT) is a stilbenoid found in various natural sources, emerging as an antioxidant with potential preventive and therapeutic properties in numerous diseases. Despite its promising properties, PT's low water solubility and bioavailability pose challenges.
Nutraceutical co-crystallization is a recent strategy to enhance solubility and oral bioavailability. It has been identified that a new pterostilbene:picolinic acid (1:1) co-crystal, significantly increasing solubility and oral bioavailability compared to commercial free base PT.
The study aims to evaluate oral bioavailability (AUC0-24h) of PT (free and total) from ccPT compared to commercial PT, using two different encapsulation methods. Secondary objectives include determining pharmacokinetic parameters such as AUCinf, relative oral bioavailability (Frel), Cmax, Tmax, and T1/2 for both free and total PT.
This randomized, crossover, single-blind clinical trial aims to provide insights into the effectiveness of the new ccPT formulation in enhancing PT's oral bioavailability compared to the commercial PT formulation.
- Conditions
- Biological Availability
- Being tested
- Pterostilbene cocrystal (ccPT) - Gelatin capsule, Pterostilbene free form (PT), Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule
- Keywords
- Polyphenols, Antioxidant activity, Co-crystallization, Pterostilbene, Oral bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterostilbene cocrystal (ccPT) - Gelatin capsuleDietary supplement
Participants will intake one gelatin capsule with 75 mg of Pterostilbene cocrystal (ccPT).
Pterostilbene free form (PT)Dietary supplement
Participants will intake one capsule with 50 mg of Pterostilbene free form (PT)
Pterostilbene cocrystal (ccPT) - Gastro-resistant capsuleDietary supplement
Participants will intake one gastro-resistant capsule with 75 mg of Pterostilbene cocrystal (ccPT).
| Study group | Role | What they receive |
|---|---|---|
| Pterostilbene cocrystal - gelatin capsule | Experimental | Participants consuming one gelatin capsule of Pterostilbene cocrystal (ccPT) Receives: Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gelatin capsule |
| Pterostilbene cocrystal - gastro-resistant capsule | Experimental | Participants consuming one gastro-resistant capsule of Pterostilbene cocrystal (ccPT) Receives: Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule |
| Pterostilbene free form | Active comparator | Participants consuming one capsule with Pterostilbene free form (PT) Receives: Dietary Supplement: Pterostilbene free form (PT) |
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, both free and total.
Fasting pterostilbene levels in plasma will be determined by liquid chromatography coupled to mass spectrophotometry 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).
Total PT will be quantified indirectly after hydrolysis of the conjugated glucuronide and sulfate metabolites to free PT in the presence of β-glucuronidase and arylsulfatase in the plasma samples.
Measured: At week 1, week 2 and week 3
Secondary outcomes (5)
Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total.
Fasting pterostilbene levels in plasma will be determined by liquid chromatography coupled to mass spectrophotometry 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).
Total PT will be quantified indirectly after hydrolysis of the conjugated glucuronide and sulfate metabolites to free PT in the presence of β-glucuronidase and arylsulfatase in the plasma samples.
Measured: At week 1, week 2 and week 3
Relative bioavailability of plasma pterostilbene levels (Frel).
Relative bioavailability of plasma pterostilbene levels, both free and total
Measured: At week 1, week 2 and week 3
Maximum plasma concentration (Cmax)
Maximum plasma concentration of pterostilbene, total and free.
Measured: At week 1, week 2 and week 3
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of pterostilbene, both total and free.
Measured: At week 1, week 2 and week 3
Half-life (T1/2).
Time taken for half the initial dose of pterostilbene, both total and free, administered to be eliminated from the body.
Measured: At week 1, week 2 and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start11 Mar 2024
- Primary completion7 May 2024
- Study completion7 May 2024
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
- Single blind
- Who is masked
- 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, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289140
- Sponsor's protocol ID
- BIOPTERO2
- Acronym
- BIOPTERO2
- Status last verified
- Jun 2024
- First submitted
- 23 Feb 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Oral Bioavailability of a New Formulation of Pterostilbene Co-crystal in Comparison With Its Free Form in Healthy Volunteers: Crossover, Randomized and Simple Blind Study (BIOPTERO2)
- ClinicalTrials.gov ID
- NCT06289140
- Acronym / sponsor ID
- BIOPTERO2 / BIOPTERO2
- Conditions
- Biological Availability
- Keywords
- Polyphenols, Antioxidant activity, Co-crystallization, Pterostilbene, Oral bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Circe, S.L.
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 1 Mar 2024 (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 goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:
- Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?
Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.
Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT).
Detailed description
The oxidative stress (OS) is a condition where pro-oxidative processes overwhelm cellular antioxidant defenses due to disruption in redox signaling. This results in the body's inability to eliminate reactive oxygen species (ROS) or repair damages, potentially leading to severe impacts on cells, tissues, and organs.
Pterostilbene (PT) is a stilbenoid found in various natural sources, emerging as an antioxidant with potential preventive and therapeutic properties in numerous diseases. Despite its promising properties, PT's low water solubility and bioavailability pose challenges.
Nutraceutical co-crystallization is a recent strategy to enhance solubility and oral bioavailability. It has been identified that a new pterostilbene:picolinic acid (1:1) co-crystal, significantly increasing solubility and oral bioavailability compared to commercial free base PT.
The study aims to evaluate oral bioavailability (AUC0-24h) of PT (free and total) from ccPT compared to commercial PT, using two different encapsulation methods. Secondary objectives include determining pharmacokinetic parameters such as AUCinf, relative oral bioavailability (Frel), Cmax, Tmax, and T1/2 for both free and total PT.
This randomized, crossover, single-blind clinical trial aims to provide insights into the effectiveness of the new ccPT formulation in enhancing PT's oral bioavailability compared to the commercial PT formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pterostilbene cocrystal - gelatin capsule | Experimental | Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gelatin capsuleParticipants consuming one gelatin capsule of Pterostilbene cocrystal (ccPT) |
| Pterostilbene cocrystal - gastro-resistant capsule | Experimental | Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsuleParticipants consuming one gastro-resistant capsule of Pterostilbene cocrystal (ccPT) |
| Pterostilbene free form | Active comparator | Dietary Supplement: Pterostilbene free form (PT)Participants consuming one capsule with Pterostilbene free form (PT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- 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 or the excipients.
- 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 cocrystal (ccPT) - Gelatin capsuleParticipants will intake one gelatin capsule with 75 mg of Pterostilbene cocrystal (ccPT). | Dietary supplement | Pterostilbene cocrystal - gelatin capsule |
| Pterostilbene free form (PT)Participants will intake one capsule with 50 mg of Pterostilbene free form (PT) | Dietary supplement | Pterostilbene free form |
| Pterostilbene cocrystal (ccPT) - Gastro-resistant capsuleParticipants will intake one gastro-resistant capsule with 75 mg of Pterostilbene cocrystal (ccPT). | Dietary supplement | Pterostilbene cocrystal - gastro-resistant capsule |
Primary outcome
Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels, both free and total.
Time frame: At week 1, week 2 and week 3
Fasting pterostilbene levels in plasma will be determined by liquid chromatography coupled to mass spectrophotometry 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). Total PT will be quantified indirectly after hydrolysis of the conjugated glucuronide and sulfate metabolites to free PT in the presence of β-glucuronidase and arylsulfatase in the plasma samples.
5 secondary outcomes
Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total.
Time frame: At week 1, week 2 and week 3
Relative bioavailability of plasma pterostilbene levels (Frel).
Time frame: At week 1, week 2 and week 3
Maximum plasma concentration (Cmax)
Time frame: At week 1, week 2 and week 3
Time for maximum plasma concentration (Tmax)
Time frame: At week 1, week 2 and week 3
Half-life (T1/2).
Time frame: At week 1, week 2 and week 3
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 6 Jun 2024.
- 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.
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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.
Antoni Caimari, PhD principal investigator
Fundació Eurecat
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 (ccPT) - Gelatin capsule, Pterostilbene free form (PT) and Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule 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 6 Jun 2024. 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, both free and total. (time frame: At week 1, week 2 and week 3). 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 6 Jun 2024.