NCT01301287

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

First QC Date

February 22, 2011

Last Update Submit

February 22, 2011

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12 weeks

Secondary Outcomes (1)

  • Insulin concentration during oral glucose tolerance test

    12 weeks

Study Arms (1)

Chlorella

EXPERIMENTAL
Drug: Chlorella

Interventions

ChlorellaDRUG
Chlorella

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • type 2 diabetes with less than 2 kinds of oral antidiabetes drugs
  • Hba1c: 7.0-9.0

You may not qualify if:

  • type 1 diabetes
  • pregnancy
  • acute infectious disease
  • autoimmune disease
  • hemodynamic unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, 23137, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dee Pei, MD

    Cardinal Tien Hospital 362, Chung Cheng Rd., Hsintien Taipei County 23137 Taiwan R.O.C.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fone-Ching Hsiao, MD

CONTACT

foneching.hsiao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

January 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

TW(1)