PrediabetesNCT04429737
The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients
A study testing clam protein capsules and Clam peptide plus Chlorella capsules in people with Prediabetes and Metabolic Diseases, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Prediabetes, Metabolic Diseases, Glucose Metabolism Disorders
- What is being tested?
- clam protein capsules and Clam peptide plus Chlorella capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Mar 2017to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Center for traditional chinese medicine, Chang Gung Memorial Hospital
Gueishan Township, Taoyuan County, 33378
TSE-HUNG HUANG MD PhD
Keelung, 204
About this study
Official title: 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.
Read the 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.
- Conditions
- Prediabetes, Metabolic Diseases, Glucose Metabolism Disorders, Dietary Supplement, Nutrition
- Being tested
- clam protein capsules, Clam peptide plus Chlorella capsules, Placebo
- Keywords
- Prediabetes, Glucose Metabolism Disorders, Metabolic Diseases, Clam protein capsules, Clam peptide, Clam amino capsules, clam extract
- Medical subject headings
- Prediabetic State, Metabolic Diseases, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clam protein capsulesDietary supplement
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.
Clam peptide plus Chlorella capsulesDietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: clam protein capsules; Dietary Supplement: Clam peptide plus Chlorella capsules |
| placebo | Placebo comparator | The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Measured: 3 months
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline
Measured: 3 months
Assessment of the change in Albumin (g/L) relative to baseline
Assessment of the change in Albumin (g/L) relative to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Mar 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhao Hong Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- TSE-HUNG HUANG, MD PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429737
- Sponsor's protocol ID
- Chang Gung IRB 201601965A3
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital
- ClinicalTrials.gov ID
- NCT04429737
- Acronym / sponsor ID
- Chang Gung IRB 201601965A3
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Zhao Hong Biotechnology Co., Ltd.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: clam protein capsules, Dietary Supplement: Clam peptide plus Chlorella capsulesThe 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 comparator | Dietary Supplement: PlaceboThe prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clam protein capsulesThe 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 | Experimental |
| Clam peptide plus Chlorella capsulesThe 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. | Dietary supplement | Experimental |
| PlaceboThe 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. | Dietary supplement | placebo |
Primary outcome
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
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
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
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
Assessment of the change in HbA1C (%) relative to baseline
Time frame: 3 months
Assessment of the change in HbA1C (%) relative to baseline
Assessment of the change in HbA1C (%) relative to baseline
Time frame: 6 months
Assessment of the change in HbA1C (%) relative to baseline
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSE-HUNG HUANG, MD PhD principal investigator
Chang Gung Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clam protein capsules and Clam peptide plus Chlorella capsules in people with Prediabetes and Metabolic Diseases, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the change in lipid profile relative to baseline (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.