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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Metabolic Diseases; Prediabetes; Nutrition; Glucose Metabolism Disorders; Dietary Supplement

Treatments: Dietary Supplement: clam protein capsules; Dietary Supplement: Placebo; Dietary Supplement: Clam peptide plus Chlorella capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04429737

Chang Gung IRB 201601965A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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.

Treatment:

Dietary Supplement: clam protein capsules

Dietary Supplement: Clam peptide plus Chlorella capsules

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo