A 4 week, Randomized, Double-blind, Parallel Clinical Trial for the Evaluation of the Efficacy and safety of fermented soybeans (Doenjang, DJ) for improving gut bacteria and metabolic diseases indicators
- Conditions
- Not Applicable
- Registration Number
- KCT0006223
- Lead Sponsor
- Microbial Institute for Fermentation Industry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
1) Male or female subjects aged from 19 to 70 years old
2) Fasting glucose of 100-125 mg/dL or glycated hemoglobin (HbA1c) of 5.7-6.4%
3) Subjects who voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this human application test
1) People who have been diagnosed with type 1 or type 2 diabetes
2) A person who has taken drugs such as hypoglycemic drugs, obesity drugs, lipid-lowering drugs, within 3 month from the screening test date
3) A person who has taken a specialized medicine, herbal medicine, or health functional food related to intestinal health within 1 month from the date of screening examination
4) Patients with clinically significant acute or chronic cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, Digestive system, rectal anal disease, endocrine system, musculoskeletal, inflammatory and blood and tumor diseases
5) A person who has a history of overreacting or clinically significant hypersensitivity to drugs and human test products
6) Patients with a history of gastrointestinal diseases (such as Crohn's disease) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that can affect the absorption of nutrients
7) Those who continue to take anti-psychotic drugs within 2 months prior to the screening test
8) Those who participated in another human study within 3 months before the screening test
9) Those suspected of alcoholism or drug abuse or who has a history
10) Those who showed the following results in a diagnostic examination
? Serum AST, ALT > 3 times the upper limit of the reference range
? Serum creatinine > 2.0mg/dL
11) Pregnant or lactating women
12) Women of childbearing potential who are likely to become pregnant and do not accept the implementation of appropriate contraceptive methods (expect for women who have undergone sterilization)
13) Subjects who are judged to be unsuitable for participation in the research due to the results of diagnostic laboratory medical examination and other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gut bacteria
- Secondary Outcome Measures
Name Time Method Gastrointestinal symptom rating scale(KGSRS), Blood glucose index(fasting blood glucose, HbA1c), Body measurement indicator, Lipid index, Arteriosclerosis index, Inflammation index;Adverse Events, Vital sign;Physical examination, Electrocardiogram, Laboratory data