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

Hadassah Medical Center

Status and phase

Completed

Phase 1

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Hoodia gordonii

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00816465

HoodiaNAFLD-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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