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

Not Applicable

• Conditions: Prediabetes; Metabolic Diseases; Dietary Supplement; Glucose Metabolism Disorders; Nutrition
• Interventions: Dietary Supplement: clam protein capsules; Dietary Supplement: Placebo; Dietary Supplement: Clam peptide plus Chlorella capsules

• Registration Number: NCT04429737
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of the change in lipid profile relative to baseline	6 months	Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
Assessment of the change in inflammation index relative to baseline	6 months	Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline	6 months	Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in liver function relative to baseline	6 months	Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
Assessment of the change in renal function relative to baseline	6 months	Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline	6 months	Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline	6 months	Assessment of the change in fasting glucose (mg/dl) relative to baseline

Trial Locations

Locations (2)

Center for traditional chinese medicine, Chang Gung Memorial Hospital; 🇨🇳 Gueishan Township, Taoyuan County, Taiwan

TSE-HUNG HUANG MD PhD; 🇨🇳 Keelung, Taiwan