1. Home
  2. Approved trials
  3. » فارسی

Comparing the effects of aerobic exercises and low-calorie diet on inflammation and insulin resistance, a randomized clinical trial

Protocol summary

Study aim
Effects of aerobic exercise and low-calorie diet on inflammatory indices and insulin resistance in healthy middle-aged obese men without diabetes
Design
Controlled clinical trial with a parallel group design, single-blinded, randomized using block randomization method, including 90 participants (i.e. 45 in each group).
Settings and conduct
For subject selection, the physical education organization of the district under study (Fasa, town in sout east of fars province in Iran) submitted a recall. A total of 90 individuals entered the study, who were randomly assigned into two groups: one group (n=45) received diet therapy, while the other group (n=45) underwent exercise under the supervision of the study executor.
Participants/Inclusion and exclusion criteria
The inclusion criteria was signed informed consent, continuous inactivity, and having an BMI greater than 25. . Also, people with metabolic problems such as thyroid disease, cancer, lipid problems, blood glucose (diabetic maple), liver or kidney disease were excluded.
Intervention groups
The first group received a special diet that provides 500 calories less than the daily requirement calculated. The second group performed moderate intensity (60-75% of the maximum heart rate on the treadmill).
Main outcome variables
laboratory indicators including leptin, adiponectin, Chemerin, FBS, fasting insulin, insulin resistance index (HOMA-IR), hs CRP inflammatory index, interleukin 1β, and interleukin-6.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110811007297N6
Registration date: 2020-01-17, 1398/10/27
Registration timing: retrospective

Last update: 2020-01-17, 1398/10/27
Update count: 0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
Mojtaba Heydari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7679
Email address
mheydari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
2019-05-05, 1398/02/15
Actual recruitment end date
2019-08-06, 1398/05/15
Trial completion date
2019-08-15, 1398/05/24
Scientific title
Comparing the effects of aerobic exercises and low-calorie diet on inflammation and insulin resistance, a randomized clinical trial
Public title
Comparing the effects of aerobic exercises and low-calorie diet on insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no constant physical activity BMI above 25
Exclusion criteria:
those with metabolic problems and diseases including thyroid disease, cancer, lipid profile problems, blood sugar, blood pressure, liver and kidney diseases those who used any special diet or had changed their diet over the past six months
Age
From 35 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization for individuals (18 blocks with equal size of 5, non-stratified); randomization tool: table of random digits generated using Microsoft Excel software; allocation concealment: sequentially numbered sealed opaque envelopes which included groups' codes (according to the table of random digits). The secretary of ward will take an envelop (according to the sequence of referred patient). Then, patient's first name (to save patients' confidentiality) will be written on the envelop. Now, it will be opened and patient's group will be determined accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
data collectors, outcome assessors, and bio-statistician
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences . Ethics department
City
Fasa
Province
Fars
Postal code
7135644144
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.FUMS.REC.1398.072

Health conditions studied

1

Description of health condition studied
People with overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
leptin, adiponectin, Chemerin, FBS, fasting insulin, insulin resistance index (HOMA-IR), hs CRP inflammatory index, interleukin 1β, and interleukin-6.
Timepoint
Before the intervention and 12 weeks later
Method of measurement
Blood sample

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: special diet that provides 500 calories less than the TEE (including 50-50% carbohydrate, 15-20% protein and 30-25% fat), totally 3500 per week.
Category
Lifestyle

2

Description
Second intervention group: performed moderate exercise (60-75% of the maximum heart rate). Exercise for these people started at 90 minutes a week, was divided into three doses, and the heart rate was monitored through a monitor on the device. Duration of the session (10-15 minutes for each session) and the number of training sessions (started three times a week and reached seven sessions per week) was increased, at the end of intervention each person had an average of 200-300 minutes per week aerobic exercise in his program, equivalent to the 1400-2100 MET (3500 kcal/week)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
The physical education organization of the district under study (Fasa, town in south east of Fars pr
Full name of responsible person
Seyed Reza Hojati
Street address
Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7135644144
Phone
+98 21 8670 5503
Email
hojjati@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Seyed Reza Hojati
Street address
Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7135644144
Phone
+98 21 8670 5503
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Reza Homayounfar
Position
Associate Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7135644144
Phone
+98 21 8670 5503
Email
r_homayounfar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Reza Homayounfar
Position
Associate Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7135644144
Phone
+98 21 8670 5503
Email
r_homayounfar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Seyed Reaza Hojati
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7135644144
Phone
+98 21 8670 5503
Email
hashempur@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Along with published article and for ever.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
There is no restriction on this matter. Requests will be reviewed by corresponding author.
From where data/document is obtainable
Professor Reza Homayounfar via his email: homayounfar@sbmu.ac.ir
What processes are involved for a request to access data/document
Researchers should email their request and their topic of researches. Response will be available within 7 working days.
Comments
Loading...