Dietary Supplement, Glucose Metabolism Disorders, Metabolic Diseases, Nutrition, Prediabetes
Conditions
Keywords
Prediabetes, Glucose Metabolism Disorders, Metabolic Diseases, Clam protein capsules, Clam peptide, Clam amino capsules, clam extract
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 prediabetes patients to become diabetes.
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 prediabetes patients to become diabetes., 3 month and 6 month data will be collected and put into analysis to provide some suggestions on the Clam protein capsules and Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.
Interventions
DIETARY_SUPPLEMENTclam protein capsules
The prediabetes patients in this arm will receive Clam protein capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
DIETARY_SUPPLEMENTClam peptide plus Chlorella capsules
The prediabetes patients in this arm will receive Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
DIETARY_SUPPLEMENTPlacebo
The prediabetes patients in this arm will receive Placebo with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
Sponsors
Zhao Hong Biotechnology Co., Ltd.
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Agree to cooperate in the trial and sign the written informed consent 2. Age 25-70 years 3. Glucose AC between 100-125 mg/dL 4. HbA1c between 5.7%\ 6.4% 5. Total Cholesterol≧160mg/dL or LDL-C≧100mg/dL Remark: Meet one of the (3)\ (5) conditions is acceptable
Exclusion criteria
1. Pregnant and lactating women 2. Poor medication compliance 3. Abnormal liver function patients (ALT and AST value\> 2 folds of normal value upper limit ) 4. Abnormal renal function patients (creatinine value\>1.5 mg/dL) 5. Abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and diarrhea) 6. Sever comorbidity in the last 6 months. (eg. Brain stroke, myocardial infarction, and major trauma and surgery) 7. Using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones, corticosteroids, H2 blockers, diuretics and Statin ) 8. Diabetes patients 9. Other sever diseases ( malignant tumor and alzheimer's disease) 10. With inflammatory diseases, infectious disease, and severe immune deficiency ( eg. tuberculosis, AIDS, active pneumonia, systemic lupus erythematosus and rheumatoid arthritis) 11. Other influence blood sugar endocrine disease (eg. Hyperthyroidism, Acromegaly, Cushing's syndrome and Pheochromocytoma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the change in fasting glucose (mg/dl) relative to baseline | 3 months | Assessment of the change in fasting glucose (mg/dl) relative to baseline |
| Assessment of the change in liver function relative to baseline | 3 months | Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline |
| Assessment of the change in lipid profile relative to baseline | 3 months | Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline |
| Assessment of the change in inflammation index relative to baseline | 3 months | Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline |
| Assessment of the change in HbA1C (%) relative to baseline | 3 months | Assessment of the change in HbA1C (%) relative to baseline |
| Assessment of the change in renal function relative to baseline | 3 months | Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline |
| Assessment of the change in Albumin (g/L) relative to baseline | 3 months | Assessment of the change in Albumin (g/L) relative to baseline |
Countries
Taiwan
Outcome results
None listed