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Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00816465
First received: December 31, 2008
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease.

Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.

Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.


Condition Intervention Phase
Non-Alcoholic Fatty Liver Disease
 Dietary Supplement: Hoodia gordonii
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • decreased insulin resistance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • reduced hepatic injury [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • reduced weight/BMI/abdominal circumference [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving Hoodia
 Dietary Supplement: Hoodia gordonii
PO administration of 1 Tab Hoodia gordoni extract per day.
Placebo Comparator: 2
Patients receiving placebo
 Other: Placebo
PO Placebo pill

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed the informed consent process culminating with written informed consent by the subject
  • Men and women age 18 to 65 years inclusive.
  • Patients with biopsy proven NASH with a score of 4 or above.
  • Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
  • HBA1C between 5.5 and 14%.

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816465

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. Refael Aharon, Yotvata - Hoodia Growers in the Arava
ClinicalTrials.gov Identifier: NCT00816465     History of Changes
Other Study ID Numbers: HoodiaNAFLD-HMO-CTIL
Study First Received: December 31, 2008
Last Updated: September 16, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Hoodia gordoni
NASH
NAFLD

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013