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

Chang Gung Memorial Hospital180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

180

Conditions

Prediabetes Metabolic Diseases Glucose Metabolism Disorders Dietary Supplement Nutrition

Interventions

clam protein capsulesDIETARY_SUPPLEMENT

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.

Clam peptide plus Chlorella capsulesDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (2)

Center for traditional chinese medicine, Chang Gung Memorial Hospital

Gueishan Township, Taoyuan County, Taiwan

TSE-HUNG HUANG MD PhD

Keelung, Taiwan

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 months

Assessment of the change in HbA1C (%) relative to baseline

Time frame: 3 months

Assessment of the change in HbA1C (%) relative to baseline

Time frame: 6 months

Assessment of the change in fasting glucose (mg/dl) relative to baseline

Time frame: 3 months

Assessment of the change in fasting glucose (mg/dl) relative to baseline

Data from ClinicalTrials.gov

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