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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Ice plant extract 2,000 mg/day for 12 weeks
Placebo 2,000 mg/day for 12 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
75-g Oral Glucose Tolerance Test (120 minute glucose)
mg/dL
Time frame: 12 weeks
Incremental Area Under the Curve 0-120 minutes
mg/dL
Time frame: 12 weeks
75-g Oral Glucose Tolerance Test (0, 30, 60, 90 minute glucose)
mg/dL
Time frame: 12 weeks
Fasting Insulin
µU/ml
Time frame: 12 weeks
Homeostasis Model Assessment for Insulin Resistance
fasting insulin (µU/ml) + fasting glucose (mg/dl)/405
Time frame: 12 weeks
Quantitative Insulin Sensitivity Check Index
1/(log(fasting insulin µU/ml) + log(fasting glucose mg/dl))
Time frame: 12 weeks
HbA1c
percentage
Time frame: 12 weeks
Total cholesterol
mg/dL
Time frame: 12 weeks
Triglyceride
mg/dL
Time frame: 12 weeks
Low-density lipoprotein cholesterol
mg/dL
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Time frame: 12 weeks
High-density lipoprotein cholesterol
mg/dL
Time frame: 12 weeks