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NCT01301287 Clinical Trial

The Effect of Chlorella on Glycemic Control of Diabetes

Diabetes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01301287
Other study ID # CTH-96-2-028
Secondary ID
Status Recruiting
Phase N/A
First received February 22, 2011
Last updated February 22, 2011
Start date January 2010

Study information
Verified date February 2011
Source Cardinal Tien Hospital
Contact Fone-Ching Hsiao, MD
Email foneching.hsiao@gmail.com
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Chlorella

Locations
Country Name City State
Taiwan Cardinal Tien Hospital New Taipei City

Sponsors (2)
Lead Sponsor Collaborator
Cardinal Tien Hospital Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c 12 weeks No
Secondary Insulin concentration during oral glucose tolerance test All subjects received the first oral glucose tolerance test before intervention(week 0), and the second oral glucose tolerance test on week 12. 12 weeks No
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