Comparing the effect of high intensity interval training and Mediterranean diet without caloric restriction on inflammatory factors and body composition in over weight and obese woman
Investigating and comparing the effect of 8 weeks of high intensity interval training and Mediterranean diet without caloric restriction on inflammatory factors and body composition in over weight and obese woman
Design
Clinical trial, with parallel arms including 3 intervention groups with 45 subjects and one control group.
Subjects will be voluntarily divided to intervention or control groups.
Settings and conduct
Overweight or obese women referring to a diet therapy center who are able and willing to participate in our study groups.
Participants/Inclusion and exclusion criteria
Age between 18-50, having a Body mass index over 25, not being pregnant of lactating
Intervention groups
Intervention groups will take part in a high intensity interval training program, or Mediterranean diet program, or will receive both interventions for 8 weeks
Main outcome variables
Body Mass Index, Fat Mass, Waist Hip Ratio, Interleukin-6, Leptin, Adiponectin, Tumor Necrosis Factor alpha, C-Reactive Protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013107N4
Registration date:2022-12-03, 1401/09/12
Registration timing:retrospective
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Maryam Koushkie Jahrimi
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 71 1613 4666
Email address
mkoushki@rose.shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
2022-07-30, 1401/05/08
Actual recruitment end date
2022-08-11, 1401/05/20
Trial completion date
2022-10-13, 1401/07/21
Scientific title
Comparing the effect of high intensity interval training and Mediterranean diet without caloric restriction on inflammatory factors and body composition in over weight and obese woman
Public title
Comparing the effect of high intensity interval training and Mediterranean diet on inflammatory factors and body composition
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-50 years old
BMI over 25
Exclusion criteria:
pregnant or lactating women
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
47
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shiraz University
Street address
Eram sq.
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Approval date
2022-07-15, 1401/04/24
Ethics committee reference number
IR.US.REC.1401.009
Health conditions studied
1
Description of health condition studied
overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Body Mass Index
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
body analyzer and stadiometer
2
Description
Fat Mass
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
body analyzer
3
Description
Waist Hip Ratio
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
tape
4
Description
Interleukin-6
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
laboratory kit
5
Description
Leptin
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
laboratory kit
6
Description
Adiponectin
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
laboratory kit
7
Description
Tumor Necrosis Factor alpha
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
laboratory kit
8
Description
C reactive protein
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: High intensity interval training. In this group, subjects would exercise on a stationary bike, 3 sessions a week for 8 weeks (24 sessions). Each session would last 20 minutes which consists of 5 minutes warm-up, 6 bouts of 1-min efforts at 90–95% of peak heart rate (HRpeak) interspersed with 1 min of active recovery at 50–60% of HRpeak, and 3-min cooling down stretches.
Category
Lifestyle
2
Description
Intervention group 2: Mediterranean diet group. The participants will follow the principal aspects of Mediterranean diet without calorie restriction for 8 weeks.
Category
Lifestyle
3
Description
Intervention group 3: This group will receive a combination of Mediterranean diet and high intensity interval training program
Category
Lifestyle
4
Description
Control group: This group will not receive any intervention programs.