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

September 16, 2010 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decreased insulin resistance
Time Frame: 30 days
30 days
safety
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
reduced hepatic injury
Time Frame: 30 days
30 days
reduced weight/BMI/abdominal circumference
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

December 31, 2008

First Posted (ESTIMATE)

January 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoodiaNAFLD-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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