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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

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

14 years to 66 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
Drug: 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

Cardinal Tien Hospital

Collaborators

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.

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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