Galectin 3, Healthy Aging
Conditions
Keywords
Galectin 3
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTG3P-01
Nutritional supplement to promote healthy aging
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
G3 Pharmaceuticals
General Practitioners Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL) | 4 months | Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics |
| To evaluate tolerability of G3P-01 | 4 months | Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms) |
Countries
Netherlands
Outcome results
None listed