The aim of this study was to determine the effect of low carb diet and cross fit training on ghrelin, insulin and appetite levels
Design
A clinical trial including a control group with 80 participants with parallel groups, was randomized
Settings and conduct
After the initial assessments, 80 people were randomly selected as a sample in Isfahan. Then, written consent is obtained from the participants. The individuals were randomly divided into four groups. Blood samples are collected and analyzed before and after 12 weeks to measure serum ghrelin and insulin concentrations.
Participants/Inclusion and exclusion criteria
Age in the range of 25 to 40 years
Intervention groups
Intervention group 1: Low carb diet, low carb diet including 40% carbohydrates, 40% fat, and 20% protein Intervention. Group 2: Cross-fit training, training for eight weeks, and three sessions of cross-fit training per week, including weightlifting, gymnastics Intervention. Group 3: Combination (diet and exercise). Control group: without intervention.
Main outcome variables
Serum ghrelin concentration and serum insulin concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042106N1
Registration date:2021-06-16, 1400/03/26
Registration timing:registered_while_recruiting
Last update:2021-06-16, 1400/03/26
Update count:0
Registration date
2021-06-16, 1400/03/26
Registrant information
Name
Shokoofeh Samouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 1253
Email address
sh.samouei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Low-carbohydrate Diet Combined with CrossFit Training on Ghrelin levels, Insulin and Performance in Active Woman.
Public title
A review of low-carbohydrate diet and crossfit on women's performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 6 months of functional training
Normal BMI
Cardiovascular health
Don't use hormones , stimulants and fat burners drugs, During the study
Exclusion criteria:
Skeletal, muscular and metabolic problems that limiting exercise activities
Enter the menopausal period
Have blood pressure and diabetes
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
Randomization Unit: Individual;
For using a random number table, the researcher determined the reading position of the table numbers. Then the numbers were considered for different groups. After that, the numbers were recorded and assigned to four groups, including low carbohydrate diet, cross-fit training, combination, and control. Furthermore, to hide random allocation, the method of coded boxes with the random sequence was used. In this method, several boxes that are numbered based on a random sequence were provided.
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
Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
University Blvd , Arghavanie , East Gay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.138
Health conditions studied
1
Description of health condition studied
Female Athletes
ICD-10 code
Y93.B9
ICD-10 code description
Activity, other specified sports and athletics
Primary outcomes
1
Description
Serum ghrelin concentration
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Serum concentration of ghrelin by ELISA method using the Lake.Inc Monobind USA.C kit in USA
2
Description
Serum insulin concentration
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Serum concentration of insulin by ELISA method using the (Sweden, Uppsala, Mercodia) kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Low carb diet, low carb diet includes 40% carbohydrates, 40% fat and 20% protein
Category
Lifestyle
2
Description
Intervention group 2: Cross-fit training, training for 8 weeks and 3 sessions of cross-fit training per week, including weightlifting, gymnastics
Category
Rehabilitation
3
Description
Intervention group 3: Low carb diet, low carb diet including 40% carbohydrates, 40% fat and 20% protein and cross-fit workout, workout for 8 weeks and 3 sessions of cross-fit workouts per week including weightlifting, gymnastics
Category
Lifestyle
4
Description
Control group: Control group: No intervention, only follow up
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Diet Therapy , Isfahan Clinic Hospital
Full name of responsible person
Hajar Bahador
Street address
Isfahan Hospital ,Ordibehesht Ave SheikhBahaei St
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31 3233 0018
Email
H.bahador52231@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
Toghiani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
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
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
اصفهان
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
farzaneh taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD