Effects of resistance training and curcumin supplementation on the liver biochemical markers levels and structure in old women with non-alcoholic fatty liver disease
Examine the effects of nonlinear resistance training and curcumin supplementation on the liver structure and biochemical markers in obese old women with non-alcoholic fatty liver disease.
Design
Double blinded study
Settings and conduct
Forty-five obese women with non-alcoholic fatty liver disease were randomly assigned into resistance training, curcumin supplement, resistance training with curcumin supplement and placebo groups. The training groups received 12-weeks of nonlinear resistance training while control groups had a normal sedentary lifestyle. Daily, supplement groups received a curcumin capsule while plasebo group was given a placebo capsule. Blood sampling and ultrasonography were taken before and after the protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria consisted of being obese, elderly (60-71 years old) and female in addition to having fatty liver disease. The exclusion criteria were as follows: addiction to smoking, alcohol abuse, doing regular physical exercises in the last 6 months, having lung disease, kidney disease, cardiovascular disease, liver transplantation, estrogen intake, high blood pressure, chronic disorders, taking special medications such as statins, having a special dietary program, allergy to curcumin, having a cancer record and taking other supplements.
Intervention groups
Resistance training, curcumin, resistance training with curcumin and placebo.
Effects of resistance training and curcumin supplementation on the liver biochemical markers levels and structure in old women with non-alcoholic fatty liver disease
Public title
Effects of resistance training and curcumin on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being obese
Elderly (60-71 years old)
Female
Having fatty liver disease
Untrained
Exclusion criteria:
Addiction to smoking
Alcohol abuse
Doing regular physical exercises in the last 6 months
Having lung disease
Kidney disease
Cardiovascular disease
Liver transplantation
Estrogen intake
High blood pressure
Chronic disorders
Taking special medications such as statins
Having a special dietary program
Allergy to curcumin
Having a cancer
Age
From 60 years old to 71 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Each subject was assigned a code.
The codes were given to an uninformed person who was also the master of the plan.
The teacher found 45 randomly codes by using the Internet and assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects were identified using the code.
Subjects were categorized by a unknown and groups has code.
Only the code was given to the lab and the name of the subject and group was not specified.
Only the code was given to the analysis.
The supplement and placebo subjects were unaware of their group name.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Kazeroun Branch, Iran with ethical code: IR.IAU.KAU.REC.1398.079
Blood samples were taken before the intervention and 48 hours after 8 weeks of training.
Method of measurement
ALT, AST, ALP levels were measured by Pars Azmon Kit.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Resistance training: 1-The warm-up consisted of working out with a fixed bike for 8 minutes and 5 minutes of light stretching exercises. 2- The nonlinear resistance training program used in this study has been proposed by Nikseresht et al. (Nikseresht et al., 2014). Each session took about 60-70 minutes for main training (plus about 20 minutes for warm-up and cool-down), three days a week (nonconsecutive) which lasted 12 weeks.
Category
Treatment - Other
2
Description
Intervention group: Curcumin supplement: Participants in supplement groups were asked to take one curcumin capsule (Curcumin 80 mg as Nanomicelle produced by Minoo Pharmaceutical Co.) per day after breakfast.
Category
Treatment - Drugs
3
Description
Intervention group: Resistance training with curcumin supplement. This group has curcumin supplementation plus non-liner resistance exercise training.
Category
Treatment - Drugs
4
Description
Control group: Plasebo. Has no exercise training and take one placebo capsule per day after breakfast for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Science
Full name of responsible person
Mohammad Ali Azarbayjani PHD
Street address
Isfahan University of Medical Science
City
Esfahan
Province
Isfehan
Postal code
9584759378
Phone
+98 31 3792 9595
Email
m_azarbayjani@iauctb.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Niazi PhD
Street address
Islamic Azad University
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 4460 0070
Email
m_azarbayjani@iauctb.ac.ir
Grant name
Vice of Research, Central Branch, Islamic Azad University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbayjani
Position
Prof
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Sohanak
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
0214460017
Email
m_azarbayjani@iauctb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbayjani
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Sohanak
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 4460 0070
Email
m_azarbayjani@iauctb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbayjani
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Sohanak
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 4460 0070
Email
m_azarbayjani@iauctb.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Liver enzyme
When the data will become available and for how long
4 month
To whom data/document is available
Researchers
Under which criteria data/document could be used
For article
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document