NCT00820651

Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.

Conditions

• Nonalcoholic Steatohepatitis
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diamel	Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks
OTHER	Placebo and lifestyle counseling	Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with \<10% of saturated fatty acids and protein 14%, and exercise)

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-01-12
• Last updated: 2012-04-26

Locations

1 site across 1 country: Cuba