The effects of cinnamon on lipid profile, liver enzymes, insulin resistance and hs-CRP inflammatory factor, in patients with Nonalcoholic Steatohepatitis
In this study, 50 patients with Nonalcoholic Steatohepatitis (NASH) who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly assigned to receive either 6 gr cinnamon or placebos for 3 months; 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 and hs-CRP will be assessed and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207114010N9
Registration date:2013-01-11, 1391/10/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-11, 1391/10/22
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute (NNFTRI)
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of cinnamon on lipid profile, liver enzymes, insulin resistance and hs-CRP inflammatory factor, in patients with Nonalcoholic Steatohepatitis
Public title
The effects of cinnamon on lipid profile, liver enzymes,insulin resistance and hs-CRP inflammatory factor, in patients with Nonalcoholic Steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age, 18 - 65 years old; Abnormal serum transferase (ALT & AST more than 1/5 fold of normal range); Sonographic findings compatible with hepatic steatosis (degree 1 or more); NASH was diagnosed during previous 6 months; no history of alcohol consumption; absence of Pregnancy, lactation, and Professional athletic; absence of other hepatobiliary disorders, autoimmune disease, malignancies, and endocrine disorders; absence of taking any medications in last 3 months. Exclusion criteria: Evidence of any allergic reaction to cinnamon; pregnancy; disliking to continue study with any reason.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute (NNFTRI)