G3P-01 in Volunteers With Elevated Galectin-3 (Galaxy)

General Practitioners Research Institute

Status and phase: Completed; Phase 2

Conditions: Galectin 3; Healthy Aging

Treatments: Dietary Supplement: Placebo; Dietary Supplement: G3P-01

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT06398821

GPRI-23001-G3P

Details and patient eligibility

About

G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).

Enrollment: 48 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Invited through cohort study.
• Plasma galectin-3 level of 16 ng/mL or higher
• Male and female subjects ≥45 and ≤75 years of age
• Females will be non-pregnant, non-lactating, and have no intent to become pregnant during the study period.
• Able to participate in the study in the opinion of the Investigator.
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
• An Independent Ethics Committee or in Dutch Medisch- Ethische Toetsingscommissie (METC) -approved informed consent is signed and dated prior to any study-related activities.

Exclusion criteria

• Existing clinically significant concurrent medical condition which in the opinion of the Investigator may interfere with the study.
• Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening.
• Participation in a clinical trial of an investigational drug within 30 days prior to Screening, or is currently participating in another trial of an investigational drug, supplement or device.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for 30 days

Treatment:

Dietary Supplement: Placebo

G3P-01 100mg

Active Comparator group

Description:

G3P-01 100mg daily for 30 days

Treatment:

Dietary Supplement: G3P-01

G3P-01 250mg

Active Comparator group

Description:

G3P-01 250mg daily for 30 days

Treatment:

Dietary Supplement: G3P-01

G3P-01 1000mg

Active Comparator group

Description:

G3P-01 1000mg daily for 30 days

Treatment:

Dietary Supplement: G3P-01