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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00816465
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Dietary Supplement: Hoodia gordonii Other: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2009
Primary Completion Date : June 2010
Study Completion Date : August 2010


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. decreased insulin resistance [ Time Frame: 30 days ]
  2. safety [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. reduced hepatic injury [ Time Frame: 30 days ]
  2. reduced weight/BMI/abdominal circumference [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816465


Locations
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
More Information

Responsible Party: Dr. Refael Aharon, Yotvata - Hoodia Growers in the Arava
ClinicalTrials.gov Identifier: NCT00816465     History of Changes
Other Study ID Numbers: HoodiaNAFLD-HMO-CTIL
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by Hadassah Medical Organization:
Hoodia gordoni
NASH
NAFLD

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases