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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816465
• Other study ID #: HoodiaNAFLD-HMO-CTIL
• Status: Completed
• Phase: Phase 1
• First received: December 31, 2008
• Last updated: September 16, 2010
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Hoodia gordonii
PO administration of 1 Tab Hoodia gordoni extract per day.

Other:
• Placebo
PO Placebo pill

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decreased insulin resistance		30 days	No
Primary	safety		60 days	Yes
Secondary	reduced hepatic injury		30 days	No
Secondary	reduced weight/BMI/abdominal circumference		30 days	No