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The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of ice plant (Mesembryanthemum crystallinum) extract in patients with impaired fasting glucose for 12 weeks.
A previous animal study has indicated that ice plant (Mesembryanthemum crystallinum) extract (IPE) has a substantial effect on attenuating hyperglycemia and modulating gut microbiota composition in diabetic rats. Therefore, IPE might be a promising functional food for the prevention of diabetes. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of IPE in patients with impaired fasting glucose for 12 weeks; the safety of the compound is also evaluated. The Investigators examine 75-g oral glucose tolerance test (OGTT) (120 minute glucose), 75-g OGTT incremental Area Under the Curve 0-120min, 75-g OGTT (0, 30, 60, 90 minute glucose), fasting insulin, Homeostasis Model Assessment for Insulin Resistance, Quantitative Insulin Sensitivity Check Index, HbA1c, lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) at baseline and after 12 weeks of intervention. One hundred adults were administered either 2,000 mg of IPE or a placebo each day for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice plant group | Experimental | This group takes ice plant extract for 12 weeks. |
|
| Placebo group | Placebo Comparator | This group takes a placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice plant group | Dietary Supplement | Ice plant extract 2,000 mg/day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 75-g Oral Glucose Tolerance Test (120 minute glucose) | mg/dL | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve 0-120 minutes | mg/dL | 12 weeks |
| 75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose) | mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| Placebo group |
| Dietary Supplement |
Placebo 2,000 mg/day for 12 weeks |
|
| 12 weeks |
| Fasting Insulin | µU/ml | 12 weeks |
| Homeostasis Model Assessment for Insulin Resistance | fasting insulin (µU/ml) + fasting glucose (mg/dl)/405 | 12 weeks |
| Quantitative Insulin Sensitivity Check Index | 1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl)) | 12 weeks |
| HbA1c | percentage | 12 weeks |
| Total cholesterol | mg/dL | 12 weeks |
| Triglyceride | mg/dL | 12 weeks |
| Low-density lipoprotein cholesterol | mg/dL | 12 weeks |
| High-density lipoprotein cholesterol | mg/dL | 12 weeks |