The Effect of Chlorella on Glycemic Control of Diabetes | NCT01301287

Studies
The Effect of Chlorella on Glycemic Control of Diabetes

NCT01301287

Sponsor

Cardinal Tien Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2011Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Chlorella

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Name	Class
Tri-Service General Hospital (TSGH)	OTHER

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Chlorella	Experimental		Drug: Chlorella

Name	Type	Description	Arm Group Labels	Other Names
Chlorella	Drug		Chlorella

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fone-Ching Hsiao, MD	Contact			foneching.hsiao@gmail.com

Overall Officials

Name	Affiliation	Role
Dee Pei, MD	Cardinal Tien Hospital 362, Chung Cheng Rd., Hsintien Taipei County 23137 Taiwan R.O.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardinal Tien Hospital	Recruiting	New Taipei City		23137	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided