The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital

Conditions
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Glucose Metabolism Disorders, Prediabetes, Metabolic Diseases, Dietary Supplement, Nutrition

Intervention / Treatment
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* Dietary Supplement: clam protein capsules
* Dietary Supplement: Clam peptide plus Chlorella capsules
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The prediabetes patients in this arm will receive Clam protein capsules or 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. | Dietary Supplement: clam protein capsules<br>* 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.<br>Dietary Supplement: Clam peptide plus Chlorella capsules<br>* 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.<br>|
| Placebo Comparator: placebo<br>The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the change in lipid profile relative to baseline | Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline | 3 months | 
| Assessment of the change in lipid profile relative to baseline | Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline | 6 months | 
| Assessment of the change in inflammation index relative to baseline | Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline | 3 months | 
| Assessment of the change in inflammation index relative to baseline | Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline | 6 months | 
| Assessment of the change in HbA1C (%) 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 HbA1C (%) relative to baseline | 6 months | 
| Assessment of the change in fasting glucose (mg/dl) relative to baseline | 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 fasting glucose (mg/dl) relative to baseline | 6 months | 
| Assessment of the change in liver function relative to baseline | Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline | 3 months | 
| Assessment of the change in liver function relative to baseline | Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline | 6 months | 
| Assessment of the change in renal function relative to baseline | Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline | 3 months | 
| Assessment of the change in renal function relative to baseline | Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline | 6 months | 
| Assessment of the change in Albumin (g/L) 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 | Assessment of the change in Albumin (g/L) relative to baseline | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetes, Glucose Metabolism Disorders, Metabolic Diseases, Clam protein capsules, Clam peptide, Clam amino capsules, clam extract