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

Phase 1

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Hoodia gordonii; Other: Placebo

• Registration Number: NCT00816465
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-31
• Study First Submitted QC: 2008-12-31
• Study First Posted: 2009-01-01
• Study Start: 2009-05
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hoodia gordonii	Patients receiving Hoodia
2	Placebo	Patients receiving placebo

Primary Outcome Measures

Name	Time	Method
decreased insulin resistance	30 days
safety	60 days

Secondary Outcome Measures

Name	Time	Method
reduced hepatic injury	30 days
reduced weight/BMI/abdominal circumference	30 days

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel