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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816465

Enrollment

Registered

2009-01-01

Start date

2009-05-31

Completion date

2010-08-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Hoodia gordoni, NASH, NAFLD

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.

Interventions

DIETARY_SUPPLEMENTHoodia gordonii

PO administration of 1 Tab Hoodia gordoni extract per day.

OTHERPlacebo

PO Placebo pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
decreased insulin resistance	30 days
safety	60 days

Secondary

Measure	Time frame
reduced hepatic injury	30 days
reduced weight/BMI/abdominal circumference	30 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026