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

Primary Purpose

Prediabetes, Metabolic Diseases, Glucose Metabolism Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
clam protein capsules
Clam peptide plus Chlorella capsules
Placebo
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prediabetes focused on measuring Prediabetes, Glucose Metabolism Disorders, Metabolic Diseases, Clam protein capsules, Clam peptide, Clam amino capsules, clam extract

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Center for traditional chinese medicine, Chang Gung Memorial Hospital
  • TSE-HUNG HUANG MD PhD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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
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
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
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
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Assessment of the change in fasting glucose (mg/dl) relative to baseline
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
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
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
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
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline

Secondary Outcome Measures

Full Information

First Posted
May 5, 2020
Last Updated
June 10, 2020
Sponsor
Chang Gung Memorial Hospital
Collaborators
Zhao Hong Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04429737
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Zhao Hong Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
clam protein capsules
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Clam peptide plus Chlorella capsules
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the change in lipid profile relative to baseline
Description
Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
Time Frame
3 months
Title
Assessment of the change in lipid profile relative to baseline
Description
Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
Time Frame
6 months
Title
Assessment of the change in inflammation index relative to baseline
Description
Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
Time Frame
3 months
Title
Assessment of the change in inflammation index relative to baseline
Description
Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
Time Frame
6 months
Title
Assessment of the change in HbA1C (%) relative to baseline
Description
Assessment of the change in HbA1C (%) relative to baseline
Time Frame
3 months
Title
Assessment of the change in HbA1C (%) relative to baseline
Description
Assessment of the change in HbA1C (%) relative to baseline
Time Frame
6 months
Title
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Description
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Time Frame
3 months
Title
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Description
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Time Frame
6 months
Title
Assessment of the change in liver function relative to baseline
Description
Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
Time Frame
3 months
Title
Assessment of the change in liver function relative to baseline
Description
Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
Time Frame
6 months
Title
Assessment of the change in renal function relative to baseline
Description
Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
Time Frame
3 months
Title
Assessment of the change in renal function relative to baseline
Description
Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
Time Frame
6 months
Title
Assessment of the change in Albumin (g/L) relative to baseline
Description
Assessment of the change in Albumin (g/L) relative to baseline
Time Frame
3 months
Title
Assessment of the change in Albumin (g/L) relative to baseline
Description
Assessment of the change in Albumin (g/L) relative to baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TSE-HUNG HUANG, MD PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for traditional chinese medicine, Chang Gung Memorial Hospital
City
Gueishan Township
State/Province
Taoyuan County
ZIP/Postal Code
33378
Country
Taiwan
Facility Name
TSE-HUNG HUANG MD PhD
City
Keelung
ZIP/Postal Code
204
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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