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The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

D

Dr Azita Hekmatdoost

Status and phase

Completed
Phase 3
Phase 2

Conditions

Non Alcoholic Fatty Liver

Treatments

Dietary Supplement: Resveratrol
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 and older;
  • Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography;
  • No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men;
  • Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders;
  • Absence of pregnancy or lactation;
  • Absence of taking any medications in the past three months;
  • Absence of weight loss in the recent three months;
  • Absence of endocrine and metabolism disorders.

Exclusion criteria

  • Weight loss more than 10% of baseline body weight during the intervention period.
  • Pregnancy;
  • Disliking to continue the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Resveratrol
Active Comparator group
Description:
Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks
Treatment:
Dietary Supplement: Resveratrol
Placebo
Placebo Comparator group
Description:
one capsule per day
Treatment:
Other: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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