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| Name | Class |
|---|---|
| G3 Pharmaceuticals | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for 30 days |
|
| G3P-01 100mg | Active Comparator | G3P-01 100mg daily for 30 days |
|
| G3P-01 250mg | Active Comparator | G3P-01 250mg daily for 30 days |
|
| G3P-01 1000mg | Active Comparator | G3P-01 1000mg daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G3P-01 | Dietary Supplement | Nutritional supplement to promote healthy aging |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL) | Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics | 4 months |
| To evaluate tolerability of G3P-01 | Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms) | 4 months |
| To evaluate tolerability of G3P-01 | Number of participants with abnormal laboratory tests results | 4 months |
| To evaluate tolerability of G3P-01 | Number of participants with abnormal physical examination findings | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J WH Kocks, MD, PhD | General Practitioners Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practitioners Research Institute | Groningen | Netherlands |
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| Placebo | Dietary Supplement | Placebo |
|