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

June 10, 2020 updated by: Chang Gung Memorial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of the change in lipid profile relative to baseline
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 3 months
Assessment of the change in HbA1C (%) relative to baseline
3 months
Assessment of the change in HbA1C (%) relative to baseline
Time Frame: 6 months
Assessment of the change in HbA1C (%) relative to baseline
6 months
Assessment of the change in fasting glucose (mg/dl) relative to baseline
Time Frame: 3 months
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
Time Frame: 6 months
Assessment of the change in fasting glucose (mg/dl) relative to baseline
6 months
Assessment of the change in liver function relative to baseline
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 3 months
Assessment of the change in Albumin (g/L) relative to baseline
3 months
Assessment of the change in Albumin (g/L) relative to baseline
Time Frame: 6 months
Assessment of the change in Albumin (g/L) relative to baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhao Hong Biotechnology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TSE-HUNG HUANG, MD PhD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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