The effect of aerobic and resistance exercise with and without pomegranate concentrate on lipid profiles and glycemic Indices in inactive obese women with metabolic syndrome
The effect of aerobic-resistance exercise training with and without pomegranate concentrate consumption on some metabolic syndrome indices in obese middle-aged women
Design
Sixty obese women with metabolic syndrome are selected through convenience sampling. Participants are randomly divided into four groups.
Settings and conduct
Sixty obese women with metabolic syndrome are selected through convenience sampling. Participants are randomly divided into four groups according to blood sampling: the first group was aerobic-resistance training without pomegranate concentrate, and the second group was aerobic-resistance training with pomegranate concentrate, the third group is exclusively pomegranate concentrate and the fourth group (without exercise program and consumption of pomegranate concentrate).
The planned sports program will be conducted for the first and second groups for 3 months. Participants in the second and third groups will use 50 grams of pomegranate concentrate daily for three months.
After the intervention, secondary blood sampling will be obtained to measure lipid profile and glycemic indices.
Participants/Inclusion and exclusion criteria
Obese women with metabolic syndrome
Age 35-45 years
32>BMI>27
No training course for at least 2 months prior to the training
no affliction with chronic diseases such as cardiovascular, renal disorders, or thyroid disorders
consuming no medications
Intervention groups
1: Exercise
2: Exercise with pomegranate concentrate consumption
3: daily consumption of pomegranate concentrate
4: Control
Main outcome variables
Glycemic indices and lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181029041491N1
Registration date:2018-11-28, 1397/09/07
Registration timing:retrospective
Last update:2018-11-28, 1397/09/07
Update count:0
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
Mohammadali Sardar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2178
Email address
sardarma@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
2018-08-01, 1397/05/10
Actual recruitment end date
2018-09-01, 1397/06/10
Trial completion date
2018-12-01, 1397/09/10
Scientific title
The effect of aerobic and resistance exercise with and without pomegranate concentrate on lipid profiles and glycemic Indices in inactive obese women with metabolic syndrome
Public title
ٍEffect of exercise and pomegranate concentrate on metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
inactive obese women (35-45 age ) with metabolic syndrome
32>BMI>27
no training course for at least 2 months prior to the training
no affliction with chronic diseases such as cardiovascular, renal disorders, or thyroid disorders
no menopause
non-smokers
consuming no medications
Exclusion criteria:
Unwillingness to continue the study
the disease that requires special treatments
Severe change in diet
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign randomness to the first one, it is poured into a repository code A, B, C, and D, and for the first one a picking code is removed, and then the research unit is assigned in one of the following groups, respectively To find
Group 1: Aerobic- Resistance Exercise
Second group: Aerobic - Resistant Exercise Concentrate with Pomegranate
Group 3: daily consumption of pomegranate concentrate
Group 4: Control (no exercise and no pomegranate concentrate)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi Square, Paradise Daneshgah, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.064
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
fasting blood sugar
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
2
Description
fasting insulin
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
3
Description
glycosylated hemoglobin
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
4
Description
C-peptide
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
5
Description
cholesterol
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
6
Description
TG
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
7
Description
HDL
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
8
Description
LDL
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
Blood sampling
9
Description
Insulin Resistance
Timepoint
24 hours prior to the protocol and 48 hours after the last protocol session
Method of measurement
homeostasis model assessment (HOMA-IR) formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: consume a daily amount of pomegranate concentrate (50 g) in two meals of 25 g after lunch and dinner
Category
Prevention
2
Description
Intervention group: combination of aerobic and resistance exercises for 3 month
Category
Prevention
3
Description
Intervention group: combination of aerobic and resistance exercises for 3 month with consume a daily amount of pomegranate concentrate
Category
Prevention
4
Description
Control group: No exercise; No pomegranate concentrate consumption
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Sardar
Street address
Azadi Square, Paradise Daneshgah, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2178
Email
sardarma@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Azadi Square, Paradise Daneshgah, School of pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadali Sardar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Paradise Daneshgah, Azadi Square , Mashad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2178
Fax
+98 51 3800 2173
Email
sardarma@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Sardar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Azadi Square, Paradise Daneshgah, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2178
Email
sardarma@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ali Sardar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Azadi Square, Paradise Daneshgah, School of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2178
Email
sardarma@mums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main implications
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
To repeat the research / use the results of the research in review studies
From where data/document is obtainable
Corresponding Author: Mohammad Ali Sardar sardarma@mums.ac.ir
What processes are involved for a request to access data/document
Up to one month after receiving the email from the applicant, the paper file published by the author is sent to him