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

NCT04429737 | Unknown

• 1 other identifier: Chang Gung IRB 201601965A3
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

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

PLACEBO COMPARATOR

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

clam protein capsules DIETARY_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.

Experimental

Clam peptide plus Chlorella capsules DIETARY_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.

Experimental

Placebo DIETARY_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.

placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Zhao Hong Biotechnology Co., Ltd.: collaborator

Study Sites (2)

Center for traditional chinese medicine, Chang Gung Memorial Hospital

Gueishan Township, Taoyuan County, 33378, Taiwan

Location

TSE-HUNG HUANG MD PhD

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Prediabetic State; Metabolic Diseases; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• TSE-HUNG HUANG, MD PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: June 12, 2020
• Study Start: March 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 12, 2020

Record last verified: 2020-05

Locations

TW (2)