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The Effect of Chlorella on Glycemic Control of Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Cardinal Tien Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by:
Cardinal Tien Hospital
ClinicalTrials.gov Identifier:
NCT01301287
First received: February 22, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia, especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella through increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic patients have not been studied. In order to clarify the hypoglycemic effects and mechanism of Chlorella in diabetic patients, the investigators conducted a 12-week randomized, double-blind, placebo-control trial on diabetic patients.


Condition Intervention
Diabetes
 Drug: Chlorella

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardinal Tien Hospital:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin concentration during oral glucose tolerance test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    All subjects received the first oral glucose tolerance test before intervention(week 0), and the second oral glucose tolerance test on week 12.


Estimated Enrollment: 30
Study Start Date: January 2010
Arms Assigned Interventions
Experimental: Chlorella Drug: Chlorella

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years old
  • type 2 diabetes with less than 2 kinds of oral antidiabetes drugs
  • Hba1c: 7.0-9.0

Exclusion Criteria:

  • type 1 diabetes
  • pregnancy
  • acute infectious disease
  • autoimmune disease
  • hemodynamic unstable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301287

Contacts
Contact: Fone-Ching Hsiao, MD foneching.hsiao@gmail.com

Locations
Taiwan
Cardinal Tien Hospital Recruiting
New Taipei City, Taiwan, 23137
Contact: Fone-Ching Hsiao, MD         foneching.hsiao@gmail.com    
Sponsors and Collaborators
Cardinal Tien Hospital
Tri-Service General Hospital
Investigators
Principal Investigator: Dee Pei, MD Cardinal Tien Hospital 362, Chung Cheng Rd., Hsintien Taipei County 23137 Taiwan R.O.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01301287     History of Changes
Other Study ID Numbers: CTH-96-2-028
Study First Received: February 22, 2011
Last Updated: February 22, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013