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Status unknownNCT04429737Updated Jun 12, 2020

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

An interventional study of clam protein capsules and Clam peptide plus Chlorella capsules in Prediabetes, Metabolic Diseases and Glucose Metabolism Disorders, sponsored by Chang Gung Memorial Hospital. Status unknown at 2 sites in Taiwan. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-12.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Mar 2017, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 180 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
180 participants (estimated)

Study arms

  • 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 · Dietary Supplement: Clam peptide plus Chlorella capsules

  • 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

Interventions

  • Dietary supplementclam 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 supplementClam 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.

  • Dietary supplementPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 6 months

  3. 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

    Time frame: 3 months

  4. 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

    Time frame: 6 months

  5. Assessment of the change in HbA1C (%) relative to baseline

    Assessment of the change in HbA1C (%) relative to baseline

    Time frame: 3 months

  6. Assessment of the change in HbA1C (%) relative to baseline

    Assessment of the change in HbA1C (%) relative to baseline

    Time frame: 6 months

  7. 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: 3 months

  8. 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

  9. 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

    Time frame: 3 months

  10. 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

    Time frame: 6 months

  11. 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

    Time frame: 3 months

  12. 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

    Time frame: 6 months

  13. Assessment of the change in Albumin (g/L) relative to baseline

    Assessment of the change in Albumin (g/L) relative to baseline

    Time frame: 3 months

  14. 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

07

Study locations

2 sites
  • Center for traditional chinese medicine, Chang Gung Memorial Hospital
    Gueishan Township, Taoyuan County 33378, Taiwan
  • TSE-HUNG HUANG MD PhD
    Keelung, 204, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04429737
Lead sponsor
Chang Gung Memorial Hospital
Collaborators
Zhao Hong Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Jun 12, 2020
Start date
Mar 1, 2017
Primary completion
Mar 2022 (estimated)
Completion
Mar 2022 (estimated)
Last update
Jun 12, 2020

Study contacts

TSE-HUNG HUANG, MD PhD
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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