Trial | NCT04429737  Report issue

Title

The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients
Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    180
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 Started
Mar 01
2017
Primary Completion
Mar 31
2022
Anticipated
Study Completion
Mar 31
2022
Anticipated
Last Update
Jun 12
2020

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.

Dietary Supplement 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.

Dietary Supplement 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.

Experimental Experimental

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.

placebo Placebo Comparator

The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules.

Criteria 

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)
No Results Posted