A Randomized, Double-blind, Crossover Trial for evaluation of efficacy and single dose safety and of fermentated sorghum power on healthy huma
- Conditions
- Not Applicable
- Registration Number
- KCT0000919
- Lead Sponsor
- Inje University Seoul Paik Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1)Male and female subjects between 20-65years of age inclusive
2)Fasting glucose or post-prandial 2 hour the normal range on screening.
3)Subjects who agree the particpation in the trial and sobmit informed and consent before the beginning of the trial.
1)Subject who taking a health functional food that affect blood glucose within the 2 weeks prior to screening.
2)Subjects who taking a hypoglycemic agent within the 3 months prior to screening.
3)TSH value =0.1uU/ml or =10 uU/ml
4)Serum creatinine = 2 times the upper limit of normal.
5)Serum AST/ALT = 3 times the upper limit of normal.
6)Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg.
7)Subjects who complain gastrointestinal symptoms such as heartburn, dyspepsia
8)Subjects who drinks alcohol 4 times per a week.
9)Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon.
10)Pregnant or possibility of pregnancy, or breast feeding mothers.
11)Designated persons who will take part in the other trial during this trial.
12)Inappropriate person decided by investigator.
13)Allergy or hypersensitivity in the sorghum.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 hours postprandial blood glucose;0GTT, AUC(0~2hr);2 hours postprandial insulin
- Secondary Outcome Measures
Name Time Method Abnormality reaction;Systolic BP, diastolic BP