- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01301287
The Effect of Chlorella on Glycemic Control of Diabetes
February 22, 2011 updated by: Cardinal Tien Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fone-Ching Hsiao, MD
- Email: foneching.hsiao@gmail.com
Study Locations
-
-
-
New Taipei City, Taiwan, 23137
- Recruiting
- Cardinal Tien Hospital
-
Contact:
- Fone-Ching Hsiao, MD
- Email: foneching.hsiao@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chlorella
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dee Pei, MD, Cardinal Tien Hospital 362, Chung Cheng Rd., Hsintien Taipei County 23137 Taiwan R.O.C.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 22, 2011
First Posted (Estimate)
February 23, 2011
Study Record Updates
Last Update Posted (Estimate)
February 23, 2011
Last Update Submitted That Met QC Criteria
February 22, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CTH-96-2-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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