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

NCT00816465 | Completed Phase 1 DMC

• 1 other identifier: HoodiaNAFLD-HMO-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Hoodia gordoni; NASH; NAFLD

Outcome Measures

Primary Outcomes (2)

• decreased insulin resistance

  30 days

• safety

  60 days

Secondary Outcomes (2)

• reduced hepatic injury

  30 days

• reduced weight/BMI/abdominal circumference

  30 days

Study Arms (2)

1

EXPERIMENTAL

Patients receiving Hoodia

Dietary Supplement: Hoodia gordonii

2

PLACEBO COMPARATOR

Patients receiving placebo

Other: Placebo

Interventions

Hoodia gordonii DIETARY_SUPPLEMENT

PO administration of 1 Tab Hoodia gordoni extract per day.

1

Placebo OTHER

PO Placebo pill

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

IL (1)