Non-Alcoholic Fatty Liver Disease Clinical Trial
Verified date | September 2010 |
Source | Hadassah Medical Organization |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | decreased insulin resistance | 30 days | No | |
Primary | safety | 60 days | Yes | |
Secondary | reduced hepatic injury | 30 days | No | |
Secondary | reduced weight/BMI/abdominal circumference | 30 days | No |
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