Protocol summary
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Study aim
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The effect of Nigella sativa supplementation on serum lipids, liver enzymes, inflammatory markers and hepatic steatosis in patients with nonalcoholic fatty liver.
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Design
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Randomized, double-blind, placebo-controlled
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Settings and conduct
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In this study, patients with non-alcoholic fatty liver reffering to Baqiatalah Hospital, with tendency to participate in the study with informed consent are recruited. After 12 to 14 hours of fasting, 5 cc of blood is taken to measure lipids profile, inflammatory factors and other serum biochemical parameters and kept in the freezer. Participants are randomly divided and classified into two groups: supplement and placebo group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18 years and above; level of liver enzymes (ALT and AST) 1.5 times greater than normal; Evidence of nonalcoholic steatohepatitis in Fibroscan. Exclusion criteria: Not continue to cooperate; consumed less than 90% of supplements at the end of the sixth and twelfth week of study.
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Intervention groups
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Patients group supplement will be recived daily 2 grams of Nigella sativa for three months and Patients in the control group will be recived placebo daily2 grams.
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Main outcome variables
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Low Density Lipoprotein Cholestrol (LDL-C), High Density Lipoprotein Cholestrol (HDL-C), Triglyceride(TG), Total Cholestrol, Fasting Blood Sugar(FBS), Insulin,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100524004010N25
Registration date:
2018-07-24, 1397/05/02
Registration timing:
registered_while_recruiting
Last update:
2019-02-09, 1397/11/20
Update count:
1
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Registration date
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2018-07-24, 1397/05/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-02-28, 1395/12/10
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Expected recruitment end date
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2018-09-21, 1397/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Nigella sativa consumption on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Non-Alcoholic Fatty Liver Disease(NAFLD)
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Public title
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The effect of Nigella sativa on Non-Alcoholic Fatty Liver Disease(NAFLD)
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
18 years old and older
Evidence of nonalcoholic steatohepatitis in Fibroscan (Controlled Attenuation Parameter (CAP) score> 263)
absence of pregnancy and lactation
Exclusion criteria:
Unwillingness to continue study for any reason.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned to receive Nigella sativa or placebo.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For randomization process, simple randomization method is used by random number table. At the beginning of the study, in order to blind the researchers to group assignment, the cans containing the capsules are coded by another person instead of the researcher to A and B as intervention and control groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-02-19, 1395/12/01
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Ethics committee reference number
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IR.SBMU.nnftri.Rec.1395.121
Health conditions studied
1
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Description of health condition studied
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Non alcoholic fatty liver disease
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ICD-10 code
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(K75.8)
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ICD-10 code description
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Other specified inflammatory liver diseases
Primary outcomes
1
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Description
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HOMA
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Timepoint
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Begining and end of the study
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Method of measurement
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Calculation
2
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Description
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TNF-α
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Timepoint
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Begining and end of the study
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Method of measurement
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Elisa
3
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Description
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IL-6
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Timepoint
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Begining and end of the study
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Method of measurement
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Elisa
4
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Description
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Hepatic Steatosis
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Timepoint
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Begining and end of the study
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Method of measurement
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Ultrasound
5
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Description
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LDL-C
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kit
6
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Description
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HDL-C
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kit
7
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Description
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TG
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kit
8
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Description
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total Cholesterol
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kit
9
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Description
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Serum Insulin
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Timepoint
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Begining and end of the study
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Method of measurement
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Radioimmunoassay
10
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Description
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FBS
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kits
11
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Description
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AST
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kits
12
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Description
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ALT
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Timepoint
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Begining and end of the study
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Method of measurement
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Enzymatic methods using a kit
13
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Description
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Total energy intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
14
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Description
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Carbohydrate intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
15
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Description
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Protein intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
16
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Description
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total fat intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
17
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Description
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SFA intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
18
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Description
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PUFA intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
19
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Description
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MUFA intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
20
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Description
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fiber intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Recall Questionare
Secondary outcomes
1
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Description
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Total energy intake
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Timepoint
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Begining and end of the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: 2 gr per day nigella sativa daily for 3 months
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Category
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Treatment - Other
2
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Description
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Placebo group: 2 gr per day starch daily for 3 months
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable