Status:
UNKNOWN
The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Zhao Hong Biotechnology Co., Ltd.
Conditions:
Prediabetes
Metabolic Diseases
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, also evaluate its ability to postpone...
Detailed Description
This study aims to evaluate the effect of freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability to postpone predi...
Eligibility Criteria
Inclusion
- Agree to cooperate in the trial and sign the written informed consent
- Age 25-70 years
- Glucose AC between 100-125 mg/dL
- HbA1c between 5.7%\~6.4%
- Total Cholesterol≧160mg/dL or LDL-C≧100mg/dL Remark: Meet one of the (3)\~(5) conditions is acceptable
Exclusion
- Pregnant and lactating women
- Poor medication compliance
- Abnormal liver function patients (ALT and AST value\> 2 folds of normal value upper limit )
- Abnormal renal function patients (creatinine value\>1.5 mg/dL)
- Abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and diarrhea)
- Sever comorbidity in the last 6 months. (eg. Brain stroke, myocardial infarction, and major trauma and surgery)
- Using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones, corticosteroids, H2 blockers, diuretics and Statin )
- Diabetes patients
- Other sever diseases ( malignant tumor and alzheimer's disease)
- With inflammatory diseases, infectious disease, and severe immune deficiency ( eg. tuberculosis, AIDS, active pneumonia, systemic lupus erythematosus and rheumatoid arthritis)
- Other influence blood sugar endocrine disease (eg. Hyperthyroidism, Acromegaly, Cushing's syndrome and Pheochromocytoma)
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04429737
Start Date
March 1 2017
End Date
March 1 2022
Last Update
June 12 2020
Active Locations (2)
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1
Center for traditional chinese medicine, Chang Gung Memorial Hospital
Gueishan Township, Taoyuan County, Taiwan, 33378
2
TSE-HUNG HUANG MD PhD
Keelung, Taiwan, 204