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

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, May 2009

First Received: December 31, 2008 Last Updated: August 10, 2009 History of Changes

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00816465

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Liver Diseases

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
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving Hoodia	Dietary Supplement: Hoodia gordonii PO administration of 1 Tab Hoodia gordoni extract per day.
2: Placebo Comparator 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

Contacts

Contact: Gadi Lalazar, MD

972-8-6778511

lalazar@hadassah.org.il

Locations

Israel
Hadassah Medical Center	Recruiting
Jerusalem, Israel, 91120
Contact: Gadi Lalazar, MD 072-8-6778511 lalazar@hadassah.org.il
Principal Investigator: Gadi Lalazar, MD

Sponsors and Collaborators

Hadassah Medical Organization

More Information

No publications provided

Responsible Party:	Yotvata - Hoodia Growers in the Arava ( Dr. Refael Aharon )
Study ID Numbers:	HoodiaNAFLD-HMO-CTIL
Study First Received:	December 31, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00816465 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Hoodia gordoni
NASH
NAFLD

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Hoodia
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on September 02, 2009