Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2)

NCT06289140 | Completed

• 1 other identifier: BIOPTERO2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Biological Availability

Keywords

Polyphenols; Antioxidant activity; Co-crystallization; Pterostilbene; Oral bioavailability

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  At week 1, week 2 and week 3

• Relative bioavailability of plasma pterostilbene levels (Frel).

  At week 1, week 2 and week 3

• Maximum plasma concentration (Cmax)

  At week 1, week 2 and week 3

• Time for maximum plasma concentration (Tmax)

  At week 1, week 2 and week 3

• Half-life (T1/2).

  At week 1, week 2 and week 3

Study Arms (3)

Pterostilbene cocrystal - gelatin capsule

EXPERIMENTAL

Participants consuming one gelatin capsule of Pterostilbene cocrystal (ccPT)

Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gelatin capsule

Pterostilbene cocrystal - gastro-resistant capsule

EXPERIMENTAL

Participants consuming one gastro-resistant capsule of Pterostilbene cocrystal (ccPT)

Dietary Supplement: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule

Pterostilbene free form

ACTIVE COMPARATOR

Participants consuming one capsule with Pterostilbene free form (PT)

Dietary Supplement: Pterostilbene free form (PT)

Interventions

Pterostilbene cocrystal (ccPT) - Gelatin capsule DIETARY_SUPPLEMENT

Participants will intake one gelatin capsule with 75 mg of Pterostilbene cocrystal (ccPT).

Pterostilbene cocrystal - gelatin capsule

Pterostilbene free form (PT) DIETARY_SUPPLEMENT

Participants will intake one capsule with 50 mg of Pterostilbene free form (PT)

Pterostilbene free form

Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule DIETARY_SUPPLEMENT

Participants will intake one gastro-resistant capsule with 75 mg of Pterostilbene cocrystal (ccPT).

Pterostilbene cocrystal - gastro-resistant capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 65 years of age.
• Sign the informed consent form.
• Know how to read, write and speak Spanish

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Circe, S.L.: collaborator

Study Sites (1)

Fundació Eurecat

Reus, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Interventions

Gelatin

Intervention Hierarchy (Ancestors)

Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Antoni Caimari, PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 11, 2024
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)