The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
Modified ADA diet in combination with controlled exercise daily 24 weeks
National Institute of Gastroenterology
Vedado, La Habana, Cuba
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
Time frame: 24 weeks
Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)
Time frame: 24 weeks
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