Protocol summary

Study aim
The effects of intermittent fasting diet with calorie restriction compared to calorie restriction diet on weight management, lipid profile, glycemic status, hormonal parameters, food addiction, appetite and gut microbiome population in people with 2-year weight regain After sleeve surgery
Design
Randomized, parallel-group, controlled, phase 3 clinical trial in 60 patients with post-sleeve weight regain, randomized blocks
Settings and conduct
The place of study is Firoozgar and Jam Hospital. Patients will be randomly divided into two groups receiving a fasting and calorie-restricted diet (30 people) or a calorie-restricted diet (30 people). Participants were asked to receive the provided diet for 12 weeks. The researcher, the people who participate in the blood collection and evaluation of the samples, and the person who will perform the statistical analysis will not know whether the person is in the intervention or control group.
Participants/Inclusion and exclusion criteria
Patients with weight regain two years after sleeve surgery and having the following conditions: Willingness to participate in the study and completing the informed consent form based on knowledge and consent to participate in the study, at least 2 years have passed since the surgery, weight gain again after from surgery (weight gain after surgery based on the definition of returning to 10% of the lowest weight recorded after surgery (Nadir)). Non-entry of pregnant and lactating people, consuming pre-biotic or probiotic products during the last one month, following a special diet, history of hospitalization during the last three months
Intervention groups
Intervention: 16:8 fasting diet with calorie restriction Control: calorie restricted diet
Main outcome variables
body weight, body fat and muscle composition, glycemic indices, lipid profile, hormonal biomarkers, gut microbiome, food addiction, appetite, impulsiveness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091114002709N64
Registration date: 2024-08-09, 1403/05/19
Registration timing: prospective

Last update: 2024-08-09, 1403/05/19
Update count: 0
Registration date
2024-08-09, 1403/05/19
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intermittent fasting diet with calorie restriction compared to calorie restriction diet on weight management, lipid profile, glycemic status, hormonal parameters, food addiction, appetite and gut microbiome population in people with 2-year weight regain After sleeve surgery: a randomized clinical trial
Public title
The effects of intermittent fasting diet with calorie restriction compared to calorie restriction diet on weight management, lipid profile, glycemic status, hormonal parameters, food addiction, appetite and gut microbiome population in people with 2-year weight regain After sleeve surgery: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and complete the informed consent form based on knowledge and consent to participate in the study At least 2 years have passed since the person's surgery Weight gain again after surgery (weight gain again after surgery based on the definition of returning 10% of The lowest recorded weight after surgery (Nadir))
Exclusion criteria:
Pregnancy and breastfeeding alcohol consumption Any addiction to opioids such as cigarettes Consumption of prebiotic or probiotic products during the last month History of hospitalization during the last three months Participating in another study within the last two months Following a special diet
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by Block Randomization method. In this method, we will select eligible people who meet the study entry criteria and then randomly place them in blocks based on age, gender and menopause status. Participants will be divided into intervention and control groups in a ratio of 1:1 by a research assistant who is not involved in the study using random blocks (www.randomization.com). For this purpose, codes A and B will be assigned to intervention and control, and researchers will not know which code is for intervention or control until the end of the study. In the method of using random blocks, we can create blocks and assign codes equally to each block. If we specify two codes in each block (the so-called block size is two), we can make two possible sequences AB and BA. When we randomize the blocks, the same codes can be assigned to each group. If the block size is four, we can make six possible sequences (AABB, ABAB, ABBA, BAAB, BABA, BBAA) and then randomize them. For example, if the block size is two, we can easily know the fact that B comes after A, or if the block size is four, we can predict what the last code will be. This is against the principle of randomization. To solve this problem, the research assistant who performs the randomization has hidden the block size from us and uses randomly mixed block sizes. For example, the block size can be two, four and six.
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 of Iran University of Medical Sciences
Street address
13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamek and Zarafshan, Quds (West) Town, Tehran
City
tehran
Province
Tehran
Postal code
1411713119
Approval date
2024-07-13, 1403/04/23
Ethics committee reference number
IR.IUMS.REC.1403.320

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
The beginning of the study (before the start of the intervention), the end of the study (12 weeks after the start of the intervention) and 3 months after the end of the study
Method of measurement
Body weight will be measured fasting, without shoes, with minimal clothing and using a digital scale (Seca, Hamburg, Germany) with an accuracy of 100 grams.

Secondary outcomes

1

Description
Body fat and muscle composition
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
Using the body analysis device of the Inbody brand

2

Description
Glycemic indices
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
Before and after the end of the intervention, 10 ml of blood samples are taken from each person in a 12-hour fasting state, and the serum sample is separated from the whole blood by a centrifuge for 10 minutes at 3500 rpm. The serum and whole blood samples are immediately frozen at -70°C until the relevant tests are performed. The standard enzyme method with commercial kits available in the market (Pars Azmon) is used to calculate insulin and FBS, HbA1c is checked by measuring in whole blood by cation exchange chromatography and using the Nyco Card HbA1c kit (Oslo, Norway). .

3

Description
lipid profile
Timepoint
TC and TG serum concentrations will be measured using laboratory methods, respectively, through enzymes such as cholesterol esterase, cholesterol oxidase, and glycerol phosphate oxidase and using standard kits. HDL will be measured after precipitation of Apolipoprotein B, which includes lipoproteins, with phosphotungstic acid. The amount of LDL will be measured using the values ​​of TC, TG, HDL and by existing formulas.
Method of measurement
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)

4

Description
Hormonal biomarkers
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
At the beginning and end of the study, 10 cc of venous blood will be extracted from the participants without the need to be fasting by qualified people. The blood sample was centrifuged, and the serum was stored at -80°C, and then the ELISA assay kit will be used to measure the levels of GLP-1, ghrelin, and BDNF.

5

Description
Gut microbiome population
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
In order to evaluate the composition of the gut microbiome, 10 grams of stool samples will be taken from people. A stool sample will be taken from a patient's excrement with the help of a special dark-colored stool collection tube and will be immediately placed in a -20 degree freezer. The bacterial DNA sample will be extracted from the stool sample in the following way:First, about 200 mg of stool sample is poured into 2 ml tubes containing 300 mg of 0.1 mm zirconia/silica beads. Lysosome from QIAamp (QIAGEN) Fecal DNA Small Kit is added to the resulting mixture and placed at 37 degrees for 30 minutes. Then the resulting mixture is shaken twice and each time for one minute at a speed of 6.5 m/s and in ASL buffer. The resulting suspension was heated at 95 °C for 5 min while shaking at 500 rpm. The DNA is then purified using the QIAamp Small Faecal DNA Kit (Favorgen) and according to the kit's instructions. The concentration and quality of the mentioned genomic material will be measured by nanodrop and electrophoresis on agarose gel. After extracting and purifying the DNA, the composition of the intestinal microbiome is determined by the Tagman Probe method using the real-time PCR method and according to the appropriate primers that will be designed for this study.

6

Description
Food addiction rate
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
Evaluation of food addiction is done by the corresponding questionnaire (Yeal) (Appendix No. 7), whose validity and reliability have been checked (98). Food addiction is a habitual behavior whose clinical criteria are similar to drug addiction (99). Yeal's questionnaire contains 35 questions, and evaluation of food addiction is done by two methods: test score and diagnosis of food addiction (suffering or not suffering from this condition). The evaluation of food addiction using the food addiction test score is done by adding the score of each of the indicators examined in this questionnaire together and obtaining a score of 0 to 7 for each person. The diagnosis of food addiction (disease or lack of it) is in such a way that if the answer to at least one of the questions related to each of the investigated indicators in the questionnaire is in favor of food addiction, a score of one will be assigned to the corresponding indicator. Finally, the scores of all indicators are added together. If the total score of the indicators is at least 3 and at least one answer to the clinical question is in favor of food addiction, the person is suffering from food addiction.

7

Description
appetite
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
The appetite questionnaire is based on the visual analog scale (VAS). This questionnaire is graded from zero to fifteen, and it is divided into five states that determine the intensity of a person's mental feelings Feeling inclined to Food measures the feeling of hunger, the feeling of satiety and the feeling of consuming food in the future.

8

Description
The degree of impulsiveness
Timepoint
The beginning of the study (before the start of the study) and the end of the study (12 weeks after the start of the study)
Method of measurement
Impulsivity is the act of acting without caution and untimely response to stimuli that often cause annoying consequences. From the perspective of psychological science, impulsive behavior is any behavior that is disproportionate to the situation and also poses a potential danger to the individual or others. The evaluation of the impulsiveness of people is done by Barrett's questionnaire, whose validity and reliability have been checked. This questionnaire measures the impulsiveness of people in the following three dimensions:• Impulsivity, lack of planning• Motor impulsivity• Cognitive impulsivity This questionnaire has 30 questions, the answer to each question is in the form of a four-point Likert scale from never to always.

Intervention groups

1

Description
Intervention group: In this group, participants will be taught that they will be allowed to eat freely from 11 am to 7 pm (for 8 hours). While from 7 pm to 11 am tomorrow (16 hours), people are only allowed to consume water, tea, coffee without sugar or any calorie-free drink. Participants will be instructed to consume a 200 kcal snack of mixed nuts (18 g fat, 5 g protein, 4 g carbohydrate) in the event of weakness and/or headache, in effect a low-carb snack. Participants in this group will be sent messages reminding them when they should fast and when they are able to eat. These messages are: Hello Good morning "Between 11:00 AM and 7:00 PM" is your eating time (message will be sent at 11:00 AM); Hello, good evening. "Between 7:00 PM and 11:00 AM tomorrow" is your fasting time (the message will be sent at 7:00 PM). In addition, the prescribed amount of calories is calculated based on the recall of actual intake and a diet of 1000-1200 calories is given. According to the same guidelines, the amount of protein intake will be 60 to 100 grams of protein per day or equivalent to 1.1 to 2.1 grams per kilogram of body weight based on the level of activity of the person. 35 to 48% of the required energy will be provided from carbohydrates and the rest of the energy will be provided from fat, which is more than 30%, and the participants will be given the necessary training to follow the diet. The diet of the control group will be divided into six daily meals including 3 main meals and 3 snacks. Based on this, a food menu will be prepared and the necessary alternatives will be taught to the people of the control group
Category
Other

2

Description
Control group: The amount of prescribed calories is calculated based on the recall of actual intake and the diet is 1000-1200 calories. According to this guideline, the amount of protein intake will be 60 to 100 grams of protein per day or equivalent to 1.1 to 2.1 grams per kilogram of body weight based on the level of activity of the person. 35 to 48% of the required energy will be provided from carbohydrates and the rest of the energy will be provided from fat, which is more than 30%, and the participants will be given the necessary training to follow the diet. The diet of the control group will be divided into six daily meals including 3 main meals and 3 snacks. Based on this, a food menu will be prepared and the necessary alternatives will be taught to the people of the control group. Participants in this group will be told to eat 3 main meals and 3 snacks. The basic instructions were as follows:"For this meal plan, you are told to eat breakfast between 8:00 am and 9:00 am. In addition, lunch between 12:00 am and 2:00 pm, and dinner between 7:00 pm and It is consumed at 21:00. Snacks should be consumed between the main meals.In order to evaluate the level of adherence to the patients' diet during the intervention, a 24-hour food diary (including two working days and one day off) will be taken from the patients at the beginning and every four weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Dr. Mahdi Alem Rajabi
Street address
Firouzgar Hospital, Beh Afrin St., Waliasr Square (AJ), Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1000
Email
mahdialemrajabi@gmail.com

2

Recruitment center
Name of recruitment center
Jam Hospital
Full name of responsible person
Dr. Mahdi Alem Rajabi
Street address
No. 86, Fajr Street, Motahari Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۸۸۶۵۷۹۱۵
Phone
+98 21 84141
Email
mahdialemrajabi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
School of Medicine, Crossroads of Shahid Hemmat and Shahid Chamran Expressways
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
rezafalak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1021
Email
farzadshidfar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
farzadshidfar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2755
Fax
+98 21 8862 2533
Email
shidfar.f@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Clinical Study Report
Yes - There is 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 data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to use the data to conduct another study or use in patients
From where data/document is obtainable
Dr Farzad Shidfar shidfar.f@iums.ac.ir
What processes are involved for a request to access data/document
Request by e-mail along with providing a complete explanation of why the data is needed
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