Clinical trial NCT04429737: The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients
Official title: Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetes
Metabolic Diseases
Glucose Metabolism Disorders
Dietary Supplement
Nutrition
Keywords: Prediabetes
Glucose Metabolism Disorders
Metabolic Diseases
Clam protein capsules
Clam peptide
Clam amino capsules
clam extract
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Zhao Hong Biotechnology Co., Ltd.
First posted: 2020-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of the change in lipid profile relative to baseline
timeFrame: 3 months
measure: Assessment of the change in lipid profile relative to baseline
timeFrame: 6 months
measure: Assessment of the change in inflammation index relative to baseline
timeFrame: 3 months
measure: Assessment of the change in inflammation index relative to baseline
timeFrame: 6 months
measure: Assessment of the change in HbA1C (%) relative to baseline
timeFrame: 3 months
measure: Assessment of the change in HbA1C (%) relative to baseline
timeFrame: 6 months
measure: Assessment of the change in fasting glucose (mg/dl) relative to baseline
timeFrame: 3 months
measure: Assessment of the change in fasting glucose (mg/dl) relative to baseline
timeFrame: 6 months
measure: Assessment of the change in liver function relative to baseline
timeFrame: 3 months
measure: Assessment of the change in liver function relative to baseline
timeFrame: 6 months
measure: Assessment of the change in renal function relative to baseline
timeFrame: 3 months
measure: Assessment of the change in renal function relative to baseline
timeFrame: 6 months
measure: Assessment of the change in Albumin (g/L) relative to baseline
timeFrame: 3 months
measure: Assessment of the change in Albumin (g/L) relative to baseline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gueishan Township
country: Taiwan
facility: Center for traditional chinese medicine, Chang Gung Memorial Hospital
state: Taoyuan County
city: Keelung
country: Taiwan
facility: TSE-HUNG HUANG MD PhD
Study officials:
affiliation: Chang Gung Memorial Hospital
name: TSE-HUNG HUANG, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: