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| Name | Class |
|---|---|
| Duke University | OTHER |
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The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting glucose.
This study will be conducted at a single study center. Approximately 40 subjects with pre-type 2 diabetes will be enrolled and randomized in this study.
This 22-week study consists of 3 periods: an 8-week treatment period (Visits 2-4), a 6-week washout period, and an 8-week treatment period (Visits 5-7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| psyllium | Experimental | 5.1 g psyllium husk in at least 8 ounces of water |
|
| Microcrsytalline Cellulose | Active Comparator | 1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psyllium | Dietary Supplement | 1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| fasting serum glucose | mean change from baseline in fasting serum glucose at 8 weeks | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McRorie, PhD | Procter and Gamble | Study Director |
| Mark Feinglos, MD | Duke University | Principal Investigator |
| Richard Surwit, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Microcrystalline Cellulose | Dietary Supplement | 1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day |
|