Protocol summary

Study aim
Effect of celery seed supplementation on serum levels of liver enzymes (AST, ALT), lipid profile (VLDL HDL, LDL, TG), glycemic index and degree of hepatic steatosis in obese and overweight non-alcoholic fatty liver patients
Design
In this double-blind, single-center clinical trial study, 44 patients with nonalcoholic fatty liver were randomly divided into two groups of 22 intervention and control group. Randomization occurs by blocking.
Settings and conduct
This study is performed on people with non-alcoholic fatty liver referred to gastrointestinal clinic in Ahvaz. Researchers and patients will not be aware of how they are randomly assigned to groups (double blind). Before and after the study, liver enzymes and lipid profiles and fasting blood glucose and insulin levels and hs-CRP and anthropometric measurements were measured.
Participants/Inclusion and exclusion criteria
Overweight and obese patients (with BMI> 25) with nonalcoholic fatty liver (grade 1, 2) having ultrasound sheet with diagnosis of nonalcoholic fatty liver with radiologist and gastroenterologist approval
Intervention groups
The intervention group received 4 capsules daily of 500 mg celery seed for 6 weeks. The control group received 4 placebo 500 mg starch capsules daily.
Main outcome variables
Fasting blood sugar, hepatic enzymes(ALT,AST), lipid profile (TG,Chol, HDL, VLDL), serum insulin, Insulin resistance index, Hs-CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191124045488N1
Registration date: 2019-11-29, 1398/09/08
Registration timing: prospective

Last update: 2019-11-29, 1398/09/08
Update count: 0
Registration date
2019-11-29, 1398/09/08
Registrant information
Name
Mahsa Samadani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3648 0181
Email address
samadani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-07, 1398/09/16
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the Effect of celery seed on serum levels of hepatic enzymes, lipid profile, glycemic parameters and hepatic steatosis degree in nonalcoholic fatty liver disease patients, with overweight and obesity
Public title
effect of celery seed on obesity and fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight and obese patients (with BMI> 25) With nonalcoholic fatty liver (grade 1, 2) having ultrasound sheet with diagnosis of nonalcoholic fatty liver with radiologist and gastroenterologist approval
Exclusion criteria:
Pregnancy and lactation liver transplantation cigarette smoking, alcohol and drugs use medications such as corticosteroids, amiodarone, tamoxifen, pracacillin, methotrexate complete intravenous nutrition heart failure, kidney disease, thyroid failure Hemochromatosis and Wilson disease Having positive test for hepatitis C, B and autoimmune hepatitis alpha-antitrypsin deficiency
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
44 subjects were divided into two groups of 22 intervention and control groups based on the block design method. In this way, an out-of-study third person who is familiar with health issues gives the supplement and placebo the same two codes as A and B. Subsequently, individuals are assigned AABB and BBAA. There are actually two 4-block blocks, each block having two A codes and two B codes. People are given codes in order to reach number 8, and repeat this number until they reach number 16. Then one of the blocks is repeated again to reach 20. Then the remaining two people receive a random code A or B code that reaches 22 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the participants are kept blind, and the third person oversees the intervention and control groups outside the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Paramedical Sciences, Golestan Boulevard, Jundishapour University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.AJUMS.REC.1398.620

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Hepatic enzymes (AST, ALT)
Timepoint
Before and after intervention
Method of measurement
Use of enzymatic kits

2

Description
Lipid profile (Triglyceride, total cholesterole, LDL, VLDL, HDL)
Timepoint
Before and after intervention
Method of measurement
Use of enzymatic kits

3

Description
Insulin levels
Timepoint
Before and after intervention
Method of measurement
Use of enzymatic kits

4

Description
Liver Echogenicity
Timepoint
Before and after intervention
Method of measurement
Using an ultrasound machine by a radiologist

5

Description
The total amount of calorie received
Timepoint
Before and after intervention
Method of measurement
Using a 24-hour food recording questionnaire

6

Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
Use of enzymatic kits

7

Description
Body fat percentage
Timepoint
Before and after intervention
Method of measurement
Using body composition measuring device

8

Description
weight
Timepoint
Before and after intervention
Method of measurement
Using digital scales

9

Description
Waist and hip circumference
Timepoint
Before and after intervention
Method of measurement
Use non-elastic tape meters

10

Description
Fasting Blood sugar
Timepoint
Before and after intervention
Method of measurement
Use of enzymatic kits

11

Description
HOMA-IR
Timepoint
Before and after intervention
Method of measurement
HOMA-IR=BS(mmol/lit)×insulin(microunit/lit)/22.5

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: getting 4 capsule of celery seed (500mg) per day fo 6 weeks.
Category
Other

2

Description
Control group: getting 4 capsules of plasebo for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Seyed Saeed Seyedian
Street address
West Pahlevan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8253
Fax
+98 61 3373 8253
Email
seyedian-ss@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan boulvared, Jundishapour University of medical sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Samadani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Boulevard, jundishapour university of medical sciences, Faculty of Paramedical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 71 3648 0181
Fax
Email
samadani.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Mohammad Shahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Boulevard, jundishapour university of medical sciences, Faculty of Paramedical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 71 3648 0181
Fax
Email
mohamadshahi-m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Samadani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Boulevard, jundishapour university of medical sciences, Faculty of Paramedical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 71 3648 0181
Fax
Email
samadani.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the financial support of this research project by Ahvaz Jundishapur University of Medical Sciences, the study data will not be allowed to be published after the intervention.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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