Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-01-20, 1402/10/30
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-10-22, 1403/08/01
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Expected recruitment end date
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2025-01-20, 1403/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of high protein meal on metabolism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-07, 1402/08/16
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1402.411
Health conditions studied
1
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Description of health condition studied
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Overweight and Obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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Resting Metabolic Rate
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Timepoint
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Resting Metabolic Rate is measured at the beginning of the study, 1, 2, 3 and 4 hours after the intervention.
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Method of measurement
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The measurement of resting metabolic rate is done by an indirect calorimetry device
Secondary outcomes
1
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Description
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Respiratory quotient
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Timepoint
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Similar to measuring Resting Metabolic Energy
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Method of measurement
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Similar to measuring Resting Metabolic Energy
2
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Description
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Blood sample variables
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Timepoint
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Similar to measuring Resting Metabolic Energy
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Method of measurement
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Similar to measuring Resting Metabolic Energy
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available