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

Prediabetes Clinical Trial

Official title:

Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04429737
• Other study ID #: Chang Gung IRB 201601965A3
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 2022

Study information

• Verified date: May 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dietary Supplement
• Glucose Intolerance
• Glucose Metabolism Disorders
• Metabolic Diseases
• Nutrition
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• clam 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.
• Clam 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.
• Placebo
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.

Locations

Country	Name	City	State
Taiwan	Center for traditional chinese medicine, Chang Gung Memorial Hospital	Gueishan Township	Taoyuan County
Taiwan	TSE-HUNG HUANG MD PhD	Keelung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Zhao Hong Biotechnology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Assessment of the change in HbA1C (%) relative to baseline	Assessment of the change in HbA1C (%) relative to baseline	3 months
Primary	Assessment of the change in HbA1C (%) relative to baseline	Assessment of the change in HbA1C (%) relative to baseline	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Assessment of the change in Albumin (g/L) relative to baseline	Assessment of the change in Albumin (g/L) relative to baseline	3 months
Primary	Assessment of the change in Albumin (g/L) relative to baseline	Assessment of the change in Albumin (g/L) relative to baseline	6 months