Investigation the effect of intermittent fasting diet in comparison with calorie restriction diet on pre-, intra- and postoperative clinical outcomes in patients undergoing sleeve gastrectomy surgery: A clinical trial
Main objective: Determining the effect of intermittent fasting diet compared to calorie restriction diet on clinical outcomes before, during and after operation in patients undergoing sleeve gastrectomy surgery.
Secondary objectives:
1-Determination and comparison of anthropometric indicators, liver size, lipid profile, liver enzyme levels at the beginning of the study and before surgery in each group and between the intervention and control groups.
2- Determining and comparing the duration of anesthesia, the duration of surgery, the amount of bleeding during the operation in each group and between the intervention and control groups.
3- Determining and comparing the rate of transfer to the intensive care unit, the duration of hospitalization and the quality of recovery in each group and between the intervention and control groups.
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, on 60 patients, with an easy sampling method, and a table of numbers will be used for randomization.
Settings and conduct
Sinai hospital surgery clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age 18-65 years;
2- Body mass index ≥ 40;
Criteria for not entering the study:
1-Vegetarian people;
2- Previous history of bariatric surgery;
3- Diabetic people treated with insulin;
4- People with uncontrolled high blood pressure;
Intervention groups
The intervention group of the 16:8 intermittent fasting diet and the control group will follow the calorie restriction diet for one month before the operation.
Main outcome variables
Anthropometric indices; liver size; lipid profile; The level of liver enzymes; duration of anesthesia; duration of surgery; the amount of bleeding during the operation; the rate of transfer to the intensive care unit; duration of hospitalization; Recovery quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200301046655N2
Registration date:2023-08-13, 1402/05/22
Registration timing:registered_while_recruiting
Last update:2023-08-13, 1402/05/22
Update count:0
Registration date
2023-08-13, 1402/05/22
Registrant information
Name
Razieh Khalooeifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
shkhalooei1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of intermittent fasting diet in comparison with calorie restriction diet on pre-, intra- and postoperative clinical outcomes in patients undergoing sleeve gastrectomy surgery: A clinical trial
Public title
Effect of fasting diet in sleeve surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Body mass index ≥ 40
A candidate for elective sleeve gastrectomy surgery
American Society of Anesthesiology classification grade: 1-2
Exclusion criteria:
Vegetarians
Previous history of bariatric surgery
Diabetics treated with insulin
People with uncontrolled high blood pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 60 people in the form of 15 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to properly implement this trial, a random allocation list will be generated separately for each of the two classes of body mass index 40 to 45 and 45 to 50.
Blinding (investigator's opinion)
Double blinded
Blinding description
the principal investigator, the surgeon, the anesthetist, the ward nurses, the person in charge of data collection and the person who evaluates the outcome will not know whether the type of diet received was intermittent fasting or calorie restriction.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Sina Hospital
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2022-09-28, 1401/07/06
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.066
Health conditions studied
1
Description of health condition studied
Sleeve gastrectomy surgery
ICD-10 code
Z98.84
ICD-10 code description
Bariatric surgery status
Primary outcomes
1
Description
liver size
Timepoint
At the beginning of the study (before the start of the intervention) and before surgery
Method of measurement
sonography
2
Description
Weight
Timepoint
At the beginning of the study (before the start of the intervention) and before surgery
Method of measurement
scales
3
Description
Body mass index
Timepoint
At the beginning of the study (before the start of the intervention) and before surgery
Method of measurement
The ratio of weight (in kilograms) to the second power of height in meters
4
Description
Lipid profile
Timepoint
At the beginning of the study (before the start of the intervention) and before surgery
Method of measurement
blood test
5
Description
Liver enzymes
Timepoint
At the beginning of the study (before the start of the intervention) and before surgery
Method of measurement
blood test
6
Description
Duration of anesthesia
Timepoint
From the time of the induction of anesthesia to extubation of the patient
Method of measurement
in minutes and from the patient's medical record
7
Description
Duration of surgery
Timepoint
The duration of surgery from the time of prep and drape to the completion of suturing
Method of measurement
in minutes and from the patient's medical record
8
Description
Duration of hospitalization
Timepoint
From the time of admission to the surgical department until discharge
Method of measurement
by day and through the patient's medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intermittent fasting diet of 16:8 type (16 hours only allowed to receive water, non-energy drinks, tea, coffee and free consumption of food for 8 hours), in case of weakness or headache, it is explained to the participants that they should eat a snack consisting of 200 kilocalories of mixed nuts (18 grams of fat, 5 grams of protein, 4 grams of carbohydrates), in fact a low carbohydrate snack. This diet will be followed for 4 weeks before sleeve gastrectomy surgery.
Category
Prevention
2
Description
Control group: The calorie restriction diet (after calculating the amount of calories required by the Mifflin method, in which the actual weight is in kilograms and height in centimeters based on the year, and by applying the coefficient of physical activity and calorific value of food, 25% of the total estimated calories will be reduced and the food plan will be adjusted for each person) will be observed for 4 weeks before the sleeve gastrectomy surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Razieh Khalooeifard
Street address
Imam Khomeini St, Hassan Abad Square
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Blvd., Qods Corner, Tehran University of Medical Sciences Headquarters
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 6634 8500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
+98 21 6634 8500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Khalooeifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
11367 46911
Phone
0098216348500
Email
shkhalooei1367@gmail.com
Web page address
https://sinahospital.tums.ac.ir/
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
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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