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The Effect of Chlorella on Glycemic Control of Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Cardinal Tien Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301287
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tri-Service General Hospital
Information provided by:
Cardinal Tien Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Further study details as provided by Cardinal Tien Hospital:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Insulin concentration during oral glucose tolerance test [ Time Frame: 12 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01301287     History of Changes
Other Study ID Numbers: CTH-96-2-028
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: February 2011