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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820651

Enrollment

158

Registered

2009-01-12

Start date

2009-11-30

Completion date

2012-04-30

Last updated

2012-04-26

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

Conditions

Insulin Resistance, Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic steatohepatitis, Insulinresistance, Diet and exercise, Nutritional supplement, Nonalcoholic fatty liver disease, Lifestyle modifications

Brief 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.

Interventions

DIETARY_SUPPLEMENTDiamel

Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks

OTHERPlacebo 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis) * Age between 18 and 70 years * Ability to provide informed consent * Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion criteria

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) * Pregnancy or lactation * Decompensated cirrhosis * Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery * Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil * Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter) * Contraindication to liver biopsy * Refusal to participate in the study * Concomitant disease with reduced life expectancy * Severe psychiatric conditions * Drug dependence

Design outcomes

Primary

Measure	Time frame
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.	52 weeks

Secondary

Measure	Time frame
Insulinresistance levels (HOMA-IR) at 52 weeks (end of the treatment), Aminotransferase levels at 52 weeks (end of the treatment), Body weight, Body Mass Index and waist circumference at 52 weeks (end of the treatment)	52 weeks

Countries

Cuba

Outcome results

None listed

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