Protocol summary

Study aim
To identify the effect of six weeks of exercise snacking and turmeric supplement on hepatic enzymes and fatty liver grade of people with non alcoholic fatty liver disease
Design
Clinical trial with control group, factorial design, single blinded, phase 3 on 40 patients. Randomization was done by an 8-sided dice.
Settings and conduct
After attending Dr. Samimi's office, participants will enter to the study, if they meet the requirements, and will be assigned to the either Exercise Snacking, Turmeric Supplement, Exercise Snacking and Turmeric Supplement, or Control group, randomly. They will be observed for six weeks and pretest and post test will be taken from them. This study is single blinded and the statistician and data analyst is not aware of the interventions.
Participants/Inclusion and exclusion criteria
The criteria for the study is being diagnosed with non alcoholic fatty liver disease and not having regular exercise and not taking turmeric supplement during a month prior to the starting date of the study.
Intervention groups
Intervention Group 1: Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises. Intervention Group 2: Turmeric Supplement: One curcumin tablet (450 milligrams) daily to be taken with food, Produced by Dineh Inc, for 6 weeks. Intervention Group 3: Exercise Snacking and Turmeric Supplement for 6 weeks. Control Group: Without any interventions
Main outcome variables
Alkaline phosphatase; Aspartate transaminase; Alanine transaminase; Fatt liver grade

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230225057528N1
Registration date: 2023-04-23, 1402/02/03
Registration timing: registered_while_recruiting

Last update: 2023-04-23, 1402/02/03
Update count: 0
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Behzad Gudarzi
Name of organization / entity
Imam Khomieni International University
Country
Iran (Islamic Republic of)
Phone
+98 21 6552 4357
Email address
s993172008@edu.ikiu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Six Weeks of Exercise Snacking and Turmeric Supplement on Hepatic Enzymes of People with Non-Alcoholic Fatty Liver Disease
Public title
The Effect of Exercise and Turmeric on non alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with non alcoholic fatty liver disease who have not taken turmeric supplement or regular exercise in the last month.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
An 8-sided dice will be used for randomization. two numbers will be assigned to each groups and the dice will be rolled for each patient, and given the number on the dice, the participants will be in one of the four groups of Exercise Snacking, Turmeric Supplement, Exercise Snacking and Turmeric Supplement, and Control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blood test analysis and sonogram will be sent to the the statistician via office clerk. The results will be entered to SPSS and they will be labeled as 1, 2, 3, 4 for three intervention groups and one control group (that only the clerk will know of) and they will be analyzed by the statistician. Therefore, the statistician is not aware of the allocation of the interventions to the participants.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of Qazvin University of Medical Sciences
Street address
Reseach and Technology Department, Maveddat Street, First Alley, Shahid Beheshti boulvard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.QUMS.REC.1401.322

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
Alanine transaminase
Timepoint
Prior to the intervention and one week after the intervention
Method of measurement
Blood test, Hitachi 912 Chemistry Analyzer

2

Description
Aspartate transaminase
Timepoint
Prior to the intervention and one week after the intervention
Method of measurement
Blood test, Hitachi 912 Chemistry Analyzer

3

Description
alkaline phosphatase
Timepoint
Prior to the intervention and one week after the intervention
Method of measurement
Blood test, Hitachi 912 Chemistry Analyzer

4

Description
Fatty liver grade
Timepoint
Prior to the intervention and one week after the intervention
Method of measurement
Ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises.
Category
Treatment - Drugs

2

Description
Intervention Group 2: Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks
Category
Lifestyle

3

Description
Intervention group 3: Turmeric Supplement and Exercise Snacking. Exercise Snacking: High intensity short intervals of bodyweight exercise lasting about 5 minutes, three times a day, three days a week for 6 weeks. The exercises are as follows: First day: Jumping Jacks, High Knee Taps, Burpee. Second day: Air Squats, Push Ups, Skater Hops. Third day: Seal Jacks, Squat Kicks, Calf Raises. Turmeric Supplement, (450 milligram) produced by Dineh Inc, One tablet daily with food for six weeks
Category
Lifestyle

4

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Samimi's Office
Full name of responsible person
Rasoul Samimi
Street address
Dr Farzam's Lab, Second Floor, South Naderi Street
City
Qazvin
Province
Qazvin
Postal code
3521456987
Phone
+98 28 3322 0100
Email
dr.samimi@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Imam Khomeini International University
Full name of responsible person
Majid Ghadiri
Street address
Imam Khomeini International University
City
Qazvin
Province
Qazvin
Postal code
٣٤١٤٨٩٦٨١٨
Phone
+98 28 3390 1144
Email
ghadiri@eng.ikiu.ac.ir
Web page address
http://ikiu.ac.ir/members/?id=211&lang=0
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Khomeini International University
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
Imam Khomieni International University
Full name of responsible person
Behzad Gudarzi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 80, 13th Shaqayeq Street
City
Andhisheh Phase 1
Province
Tehran
Postal code
3354395917
Phone
+98 21 6552 4357
Fax
Email
s993172008@edu.ikiu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Khomieni International University
Full name of responsible person
Behzad Gudarzi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 80, 13th Shaqayeq Street
City
Andhisheh Phase 1
Province
Tehran
Postal code
3354395917
Phone
+98 21 6552 4357
Fax
Email
s993172008@edu.ikiu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Imam Khomieni International University
Full name of responsible person
Behzad Gudarzi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 80, 13th Shaqayeq Street
City
Andhisheh Phase 1
Province
Tehran
Postal code
3354395917
Phone
+98 21 6552 4357
Fax
Email
s993172008@edu.ikiu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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