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Sponsor company was acquired and new owner chose not to proceed with clinical study
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The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLU-01 | Experimental |
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| GLU-02 | Experimental |
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| GLU-03 | Experimental |
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| GLU-04 | Experimental |
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| GLU-05 | Experimental |
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| GLU-06 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLU-01 | Dietary Supplement | 14 day dosing |
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| GLU-02 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose and insulin response to the Oral Glucose Tolerance Test after administration of GLU-xx formulations | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of GLU-xx formulations | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
Active diabetes mellitus [fasting blood glucose of ≥7.0 mmol/L (≥126 mg/dL) or ≥11.1 mmol/L (≥200 mg/dL) after OGTT]
Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris) or have undergone a cardiovascular intervention within the past three months
Seizure disorder
Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
Active infection, including HIV, hepatitis, etc
Participants on Estrogen replacement must be on a stable dose for at least 3 months
Serious illness requiring ongoing medical care or medication
Gastrointestinal disorders or prior gastrointestinal surgeries (including gastric bypass or lap-band) that might cause complications or influence motility or satiety (e.g.,diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
Any congenital spinal cord deformities or traumatic spinal cord injuries
Uncorrected hypothyroidism
Other significant metabolic endocrine disease
Active liver disease or liver function impairment as evidenced by a history of liver disease or liver enzyme elevations >three times the upper limit of normal
Current cancer
Significant kidney disease (calculated by eGFR <60 mL/min)
History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological,or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject
Use of anticoagulants such as warfarin
Use of medications that might affect weight or food absorption (e.g., diuretics,glucocorticoids, anorexigenic agents, Orlistat, laxatives)
Treatment within the previous 6 months with any medication that is known to affect glucose levels (such as insulin with or without an amylin analogue, sulfonylureas,meglitinides, biguanide metformin, thiazolidinediones, alpha-glucosidase inhibitors,oral dipeptidyl-peptidase-4 inhibitor, Sitagliptin, Incretin mimetic)
Regular use of natural health products or dietary supplements known to affect glucose levels (such as chromium, zinc, fenugreek, cinnamon). If the participant agrees to stop taking these products 14 days prior to study entry and for the duration of the study, they can participate in the study
o Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of < 600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng, St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of pills, extracts, capsules, or tablets. If the participant agrees to stop taking these products 14 days prior to study entry and for the duration of the study, they can participate in the study
Vegan or Vegetarian
Pregnant or lactating women, or intending to become pregnant
Known allergy to any ingredient in the study product
Any significant auto-immune disease
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| Name | Affiliation | Role |
|---|---|---|
| Jay Udani, MD | Medicus Research LLC/Staywell Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staywell Research LLC | Northridge | California | 91325 | United States |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
14 day dosing |
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| GLU-03 | Dietary Supplement | 14 day dosing |
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| GLU-04 | Dietary Supplement | 14 day dosing |
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| GLU-05 | Dietary Supplement | 14 day dosing |
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| GLU-06 | Dietary Supplement | 14 day dosing |
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