History
# Registration date Revision Id
2 2024-10-09, 1403/07/18 317176
1 2024-01-20, 1402/10/30 292011
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  • Protocol summary

    The study is carried out in a cross-sectional manner, and 30 objects receive intervention 1 in the first stage, and a week later, the same people return to receive the second intervention.
    The clinical trial study is carried out in a cross-over manner and without blinding, and 30 men and women aged 18-65 years received intervention 1 in the first stage, and a week later the same people came again to receive the second intervention. To apply randomization from The method of random blocks will be used with the help of www.randomizer.org
    مطالعه به صورت متقاطع انجام می شود و ۳۰ نفر در مرحله اول مداخله ۱ را دریافت کرده و یک هفته بعد مجدد همین افراد برای دریافت مداخله دوم مراجعه می کنند
    مطالعه کارآزمایی بالینی به صورت متقاطع و بدون کورسازی انجام می شود و ۳۰ نفر زن و مرد 18 -65 سال در مرحله اول مداخله ۱ را دریافت کرده و یک هفته بعد مجدد همین افراد برای دریافت مداخله دوم مراجعه می کنند.برای اعمال تصادفی سازی از روش بلوکهای تصادفی و با کمک سایت www.randomizer.org استفاده خواهد شد
    The study will be conducted in the Health Monitoring Center of Imam Reza Hospital in Mashhad. cases with 10 hours fasting are subjected to anthropometric evaluation and indirect calorimetry on the day of visit . Basic blood tests are also taken. After the initial evaluation, the first meal is eaten by objects within 15 minutes, and 15 minutes after that, indirect calorimetry and blood sample tests are taken. At1,2,3,4 hours after the meal, calorimetry and tests are performed according to the description. After a week of the first intervention, the same people will return to receive the second meal and the evaluations will be done according to the explanation
    The study is soon to be conducted at the Health Monitoring Center of Imam Reza Hospital in Mashhad. Participants,1 0 hours fasting, will undergo anthropometric evaluation and indirect calorimetry on the day of their visit. Basic blood tests will also be conducted. After the initial evaluation, participants are to consume the first meal within 15 minutes. Subsequently, 15 minutes later, indirect calorimetry and blood sample tests will be performed. Calorimetry and tests are then to be conducted at 1, 2, 3, and 4 hours post-meal as described. One week after the first intervention, the same participants are scheduled to return to receive the second meal, and evaluations will be conducted in the same manner.
    All overweight and obese adults without underlying diseases
    Inclusion criteria: All adults with overweight and obesity who do not have any underlying conditions Exclusion criteria: obese and overweight people who have an underlying disease
    تمام بالغین دارای اضافه وزن و چاقی که بیماری زمینه ای نداشته باشند
    شرایط ورود: تمام بالغین دارای اضافه وزن و چاقی که بیماری زمینه ای نداشته باشند شرایط عدم ورود: افراد چاق و اضافه وزن که دارای بیماری زمینه ای هستند
    - evaluation and comparing resting metabolic rate, respiratory quotient, changes in blood sugar level, thyroid hormones, serum insulin and lipid profile, adrenal hormones in both groups and between groups; Before, during and after the intervention - evaluation and comparing the appetite of each group and between groups
    Resting Metabolic rate; Respiratory Quotient; Blood Glucose; Thyroid Hormones; Serum Insulin; Lipid profile; Adrenal hormones - Measurement and comparison of appetite within and between groups
    - اندازه گیری و مقایسه انرژی متابولیسم استراحت ، ضریب تنفسی، تغییرات سطح قند خون، هورمونهای تیروئیدی، انسولین سرم و پروفایل لیپیدی،‌ هورمون های آدرنال در هر دو گروه و بین گروه ها؛ قبل، حین و پس از مداخله - اندازه گیری و مقایسه اشتها هر گروه و بین گروه ها
    متابولیسم استراحت؛ ضریب تنفسی؛ قند خون؛ هورمونهای تیروئیدی؛ انسولین سرم؛ پروفایل لیپیدی؛ هورمون های آدرنال -اندازه گیری و مقایسه اشتها هر گروه و بین گروه ها
  • General information

    2024-01-21, 1402/11/01
    2024-10-22, 1403/08/01
    2024-05-21, 1403/03/01
    2025-01-20, 1403/11/01
    empty
    One of the devices utilized in this project for assessing resting metabolic rate is the indirect calorimetry device. Considering that access to this device for students of Mashhad University of Medical Sciences is only available at the university’s Employee Health Monitoring Center, and given that the device has been undergoing repairs and was non-operational for some time, as well as the high demand for its use, permission for utilizing the device for this study has only recently been obtained. Therefore, if possible, the patient recruitment phase will be adjusted according to the latest updates.
    empty
    یکی از ابزار های مورد استفاده در این طرح جهت بررسی resting metabolic rate دستگاه کالری متری غیر مستقیم می باشد. با توجه با اینکه امکان استفاده از دستگاه برای دانشجویان دانشگاه علوم پزشکی مشهد تنها در مرکز پایش سلامت کارکنان این دانشگاه میسر می باشد و نظر به اینکه دستگاه مدتی در حال تعمیر بوده و عملیاتی نبوده است . و بدلیل ترافیک افراد متقاضی استفاده از دستگاه ، اخیرا امکان استفاده از آن برای این مطالعه کسب گردیده است. لذا در صورت امکان دوره بیمارگیری مطابق اصلاحات جدید اعمال خواهد شد.
    18 ≤ age <65
    25 ≤ BMI <40
    Weight stability for 3 months before starting the study (no more than 5% weight loss or weight gain)
    without history of bariatric surgery
    No use of weight loss medicine in the last 6 months
    Not using a weight loss diet in the last 3 months
    The participant is in perfect health status and according to the person, he does not have known GI diseases and reflux, diabetes, high blood pressure, cardiovascular diseases, liver and kidney disorders, and lipid disorders, or he does not take drugs related to these diseases. Also, don't take thyroid drugs and other drugs that affect metabolism.
    Not having heavy physical activity and not being a professional athlete (MET-min/week > 600)
    They should not be addicted to drugs and alcohol
    Do not have mental illnesses such as depression and eating disorders
    Not pregnant or lactating
    wants to lose weight and participating in the research
    18 ≤ age <65
    25 ≤ BMI <40
    Weight stability for 3 months before starting the study (no more than 5% weight loss or weight gain)
    Without history of bariatric surgery
    No use of weight loss medicine in the last 6 months
    Not using a weight loss diet in the last 3 months
    The participant should be in complete health, as stated by the individual. They should not have known gastrointestinal diseases and reflux, diabetes, hypertension, cardiovascular diseases, Liver and Kidney disorders, or lipid disorders, nor should they be taking medications related to these conditions. Additionally, they should not be using thyroid medications or other drugs that affect metabolism.
    Should not engage in intense physical activity and should not be professional athletes (MET-min/week > 600)
    Should not have addiction to drugs or alcohol
    Should not have mental health disorders such as depression and eating disorders
    Should not be pregnant or breastfeeding
    Willingness to Lose Weight and Consent to Participate in the Program
    heavy physical activity before the research
    Not fasting before studying
    Unbalanced diet in terms of composition of macronutrients in the last 24 hours
    continuous use of any drug (especially drugs that affect metabolism such as thyroid drugs, drugs that affect adrenals such as corticosteroids or drugs and alcohol on a continuous basis)
    Reluctance to cooperate
    kidney disorders, liver failure, lipid profile disorders, lack of micronutrients
    Intense physical activity before the study
    Not fasting before intervention
    Unbalanced diet in terms of composition of macronutrients in the last 24 hours
    Continuous use of any drug (especially drugs that affect metabolism such as thyroid drugs, drugs that affect Adrenals such as corticosteroids or drugs and alcohol on a continuous basis)
    Reluctance to cooperate
    Kidney disorders, Liver failure, lipid profile disorders, lack of micronutrients
  • Health conditions studied

    #1
    overweight and obesity
    Overweight and Obesity
  • Primary outcomes

    #1
    resting metabolic rate is measured at the beginning of the study, 1, 2, 3 and 4 hours after the intervention
    Resting Metabolic Rate is measured at the beginning of the study, 1, 2, 3 and 4 hours after the intervention.
  • Secondary outcomes

    #1
    respiratory quotient
    Respiratory quotient
    similar to measuring resting metabolic energy
    Similar to measuring Resting Metabolic Energy
    similar to measuring resting metabolic energy
    Similar to measuring Resting Metabolic Energy
    #2
    similar to measuring resting metabolic energy
    Similar to measuring Resting Metabolic Energy
    similar to measuring resting metabolic energy
    Similar to measuring Resting Metabolic Energy
  • Intervention groups

    #1
    گروه مداخله: در مرحله اول به افراد یک نوبت وعده غذایی پر پروتئین(25%) پر چرب(45%) کم کربوهیدرات (30%) داده می شود. کالری این وعده بر اساس ۲۵٪ انرژی مورد نیاز روزانه فرد محاسبه می شود.
    گروه مداخله: در مرحله اول به افراد یک نوبت وعده غذایی پر پروتئین(25درصد) پر چرب(45درصد) کم کربوهیدرات (30درصد) داده می شود. کالری این وعده بر اساس ۲۵درصد انرژی مورد نیاز روزانه فرد محاسبه می شود.
    #2
    گروه کنترل: در مرحله دوم به همان افراد شرکت کننده در مرحله اول به عنوان گروه کنترل وعده غذایی پر پروتئین (25%) کم چرب (15%) پر کربوهیدرات (60%) داده می شود. کالری این وعده نیز بر اساس ۲۵٪ انرژی مورد نیاز روزانه فرد محاسبه می شود.
    گروه کنترل: در مرحله دوم به همان افراد شرکت کننده در مرحله اول به عنوان گروه کنترل وعده غذایی پر پروتئین (25درصد) کم چرب (15درصد) پر کربوهیدرات (60درصد) داده می شود. کالری این وعده نیز بر اساس ۲۵درصد انرژی مورد نیاز روزانه فرد محاسبه می شود.

Protocol summary

Study aim
evaluations and comparing the acute effect of two low-calorie high-protein meals with different fat and carbohydrate content on resting metabolic rate and metabolic and blood factors in overweight and obese objects
Design
The clinical trial study is carried out in a cross-over manner and without blinding, and 30 men and women aged 18-65 years received intervention 1 in the first stage, and a week later the same people came again to receive the second intervention. To apply randomization from The method of random blocks will be used with the help of www.randomizer.org
Settings and conduct
The study is soon to be conducted at the Health Monitoring Center of Imam Reza Hospital in Mashhad. Participants,1 0 hours fasting, will undergo anthropometric evaluation and indirect calorimetry on the day of their visit. Basic blood tests will also be conducted. After the initial evaluation, participants are to consume the first meal within 15 minutes. Subsequently, 15 minutes later, indirect calorimetry and blood sample tests will be performed. Calorimetry and tests are then to be conducted at 1, 2, 3, and 4 hours post-meal as described. One week after the first intervention, the same participants are scheduled to return to receive the second meal, and evaluations will be conducted in the same manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All adults with overweight and obesity who do not have any underlying conditions Exclusion criteria: obese and overweight people who have an underlying disease
Intervention groups
Eligible cases are selected and given a high-protein, high-fat, low-carbohydrate meal according to the protocol, and acute phase evaluations (post prandial) are performed. After one week of the first phase intervention, the same objects receive a high-protein, low-fat, high-carbohydrate meal, and evaluations are performed similarly to the first phase
Main outcome variables
Resting Metabolic rate; Respiratory Quotient; Blood Glucose; Thyroid Hormones; Serum Insulin; Lipid profile; Adrenal hormones - Measurement and comparison of appetite within and between groups

General information

Reason for update
One of the devices utilized in this project for assessing resting metabolic rate is the indirect calorimetry device. Considering that access to this device for students of Mashhad University of Medical Sciences is only available at the university’s Employee Health Monitoring Center, and given that the device has been undergoing repairs and was non-operational for some time, as well as the high demand for its use, permission for utilizing the device for this study has only recently been obtained. Therefore, if possible, the patient recruitment phase will be adjusted according to the latest updates.
Acronym
IRCT registration information
IRCT registration number: IRCT20240106060633N1
Registration date: 2024-01-20, 1402/10/30
Registration timing: prospective

Last update: 2024-10-13, 1403/07/22
Update count: 1
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Saber Sahebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 7034
Email address
sahebis921@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of High protein-High Fat and High protein-High Carbohydrate meals on the Resting metabolic rate and Metabolic factors in over weight and obese adults
Public title
The effect of high protein meal on metabolism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 ≤ age <65 25 ≤ BMI <40 Weight stability for 3 months before starting the study (no more than 5% weight loss or weight gain) Without history of bariatric surgery No use of weight loss medicine in the last 6 months Not using a weight loss diet in the last 3 months The participant should be in complete health, as stated by the individual. They should not have known gastrointestinal diseases and reflux, diabetes, hypertension, cardiovascular diseases, Liver and Kidney disorders, or lipid disorders, nor should they be taking medications related to these conditions. Additionally, they should not be using thyroid medications or other drugs that affect metabolism. Should not engage in intense physical activity and should not be professional athletes (MET-min/week > 600) Should not have addiction to drugs or alcohol Should not have mental health disorders such as depression and eating disorders Should not be pregnant or breastfeeding Willingness to Lose Weight and Consent to Participate in the Program
Exclusion criteria:
Intense physical activity before the study Not fasting before intervention Unbalanced diet in terms of composition of macronutrients in the last 24 hours Continuous use of any drug (especially drugs that affect metabolism such as thyroid drugs, drugs that affect Adrenals such as corticosteroids or drugs and alcohol on a continuous basis) Reluctance to cooperate Kidney disorders, Liver failure, lipid profile disorders, lack of micronutrients
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.411

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
Resting Metabolic Rate
Timepoint
Resting Metabolic Rate is measured at the beginning of the study, 1, 2, 3 and 4 hours after the intervention.
Method of measurement
The measurement of resting metabolic rate is done by an indirect calorimetry device

Secondary outcomes

1

Description
Respiratory quotient
Timepoint
Similar to measuring Resting Metabolic Energy
Method of measurement
Similar to measuring Resting Metabolic Energy

2

Description
Blood sample variables
Timepoint
Similar to measuring Resting Metabolic Energy
Method of measurement
Similar to measuring Resting Metabolic Energy

Intervention groups

1

Description
Intervention group: In the first phase, objects are given a high-protein (25%) high-fat (45%) low-carbohydrate (30%) meal. The calories of this meal are calculated based on 25% of a person's daily energy requirement.
Category
Treatment - Other

2

Description
Control group: In the second phase, the same objects participating in the first stage as the control group are given a high protein (25%) low fat (15%) high carbohydrate (60%) meal. The calories of this meal are also calculated based on 25% of a person's daily energy requirement.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
MUMS Persian Cohort Study
Full name of responsible person
Mohsen Nemati
Street address
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
sahebis921@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Nemati
Street address
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Fax
+98 51 3800 2422
Email
NematyM@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
Saber Sahebi
Position
MD-PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
sahebis921@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saber Sahebi
Position
MD-PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
sahebis921@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saber Sahebi
Position
MD-PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences, school of medicine, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
sahebis921@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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