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IRCT20240106060633N1 IRCT 2024-01-20 Mashhad University of Medical Sciences The effect of high protein meal on metabolism 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 2024-10-22 anticipated 30 Complete https://irct.ir/trial/74854 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. N/A Overweight and Obesity. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Saber Sahebi
Mashhad University of Medical Sciences, school of medicine, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 sahebis921@mums.ac.ir Mashhad University of Medical Sciences scientific Saber Sahebi
Mashhad University of Medical Sciences, school of medicine, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 sahebis921@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 E66 Overweight and obesity Treatment - Other Treatment - Other 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. 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. 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. Respiratory quotient. Timepoint: Similar to measuring Resting Metabolic Energy. Method of measurement: Similar to measuring Resting Metabolic Energy. Blood sample variables. Timepoint: Similar to measuring Resting Metabolic Energy. Method of measurement: Similar to measuring Resting Metabolic Energy. Mashhad University of Medical Sciences Approved 2023-11-07 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, school of medicine, Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)