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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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This study is designed as a randomized, single blind (data evaluation), placebo controlled, full cross-over study and conducted in 166 (including 10% drop out) males and females, aged ≥ 18 and ≤ 65 and waist circumference of >80 cm for women and >94 cm for men (indicating increased risk of metabolic complications (WHO)) and having a sedentary lifestyle. Subjects will receive rice with a tea extract and rice without a tea extract.
There will be three visits to the test facility: one screening visit and two intervention visits. During the intervention visits venous blood samples will be collected for the analysis of plasma glucose (t = -30m, -5m, 15m, 30m, 45m, 1h, 1h 30m, 2h and 3h, relative to the start of rice consumption ) and serum insulin (t = -5m, 30m, 1h, 2h and 3h).
Between the two intervention visits subjects have an interval of one week. This interval is required to minimize subject discomfort from repeated blood sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tea extract | Active Comparator | Rice with tea extract |
|
| No tea extract | Placebo Comparator | Rice without tea extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice with tea extract | Other | Rice with tea extract |
| |
| Rice without tea extract |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the plasma glucose versus time curve | 0-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the plasma glucose versus time curve | 0-3 hours | |
| Maximum venous glucose concentration | 0-3 hours | |
| Total area under the post prandial insulin versus time curves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fergus Shanahan, Prof | Consultant Gastroenterologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | T12 H2TK | Ireland |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Other |
Rice without tea extract |
|
| 0-2 hours |
| Total area under the post prandial insulin versus time curves | 0-3 hours |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |