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

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.

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders; Metabolic Diseases; Prediabetes; Nutrition; Dietary Supplement
• Intervention / Treatment: Dietary supplement: clam protein capsules; Dietary supplement: Clam peptide plus Chlorella capsules; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan, 204
    • TSE-HUNG HUANG MD PhD
  • Taoyuan County
    • Gueishan Township, Taoyuan County, Taiwan, 33378
      • Center for traditional chinese medicine, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
PLACEBO_COMPARATOR: placebo; The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Assessment of the change in HbA1C (%) relative to baseline	Assessment of the change in HbA1C (%) relative to baseline	3 months
Assessment of the change in HbA1C (%) relative to baseline	Assessment of the change in HbA1C (%) relative to baseline	6 months
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
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
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
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
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
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
Assessment of the change in Albumin (g/L) relative to baseline	Assessment of the change in Albumin (g/L) relative to baseline	3 months
Assessment of the change in Albumin (g/L) relative to baseline	Assessment of the change in Albumin (g/L) relative to baseline	6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Zhao Hong Biotechnology Co., Ltd.
• Investigators: Principal Investigator: TSE-HUNG HUANG, MD PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Prediabetes; Glucose Metabolism Disorders; Metabolic Diseases; Clam protein capsules; Clam peptide; Clam amino capsules; clam extract
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: Chang Gung IRB 201601965A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No