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IRCT20211230053570N1 IRCT 2022-02-10 Mashhad University of Medical Sciences Postprandial effect of dietary protein source on metabolic responses The effect of dietary protein source on metabolic responses, appetite, and arterial stiffness indexes during the postprandial phase in overweight and obese men: A crossover study 2022-06-22 anticipated 46 Complete https://irct.ir/trial/61001 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: As the present study is a crossover study, all of the two study groups will receive both interventions. In the present study, only the intervention initiation meal will be randomized. Participants will be randomly allocated to animal or plant-based protein groups based on a 1:1 ratio (simple randomization). The randomization will be performed using a random number table. A random sequence will be provided and included in envelopes by someone who is not a member of the research team. Each participant will randomly choose an envelope to be allocated to one of the two test meal groups. As participants will consume both the protein meals, allocation concealment will not be done. N/A Overweight and obesity. Intervention 1: Intervention group: This group will receive an animal-based protein test meal. The test meal will provide 25% of the calculated total energy requirements and will consist of 30% protein (from animal sources), 40% carbohydrate, and 30% fat. This test meal consists of white bread, potatoes, sunflower oil, and egg, chicken, or yogurt (as the protein sources). The test meals will be prepared in the Nutrition Department kitchen at the Mashhad University of Medical Sciences, Mashhad, Iran. Chemical analysis will be performed on a sample of test meals to determine their macronutrient composition and amino acid profile. Intervention 2: Intervention group: This group will receive a plant-based protein test meal. The test meal will provide 25% of the calculated total energy requirements and will consist of 30% protein (from plant sources), 40% carbohydrate, and 30% fat. This test meal will contain white bread, potatoes, sunflower oil, lentils, and soy (as the protein sources). The test meals will be prepared in the Nutrition Department kitchen at the Mashhad University of Medical Sciences, Mashhad, Iran. Chemical analysis will be performed on a sample of test meals to determine their macronutrient composition and amino acid profile. Yes - There is a plan to make this available What will be shared: Individually nonidentifiable data of participants will be shared in this study. also, the protocol, results, and statistical analysis of the study will be published in the relevant articles When: Data will be available after the publication of the related articles (starting in 2023) To whom: Unidentifiable personal data of the participants will be made available after to other researchers at academic institutions Conditions: Unidentifiable personal data of the participants can only be used for research Where to obtain: Individually nonidentifiable information of participants can be obtained by sending an email to Dr Mohammad Safarian( safarianm@mums.ac.ir) How to obtain: Other researchers in academic institutions can send their requests by email to Dr. Mohammad Safarian. The data will be sent to them after consulting and approving the research team. Comments:
public Zahra Dehnavi
Nutrition Department,Medical School, Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2423 dehnaviz981@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Dehnavi
Nutrition Department,Medical School, Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2420 DEHNAVIZ981@MUMS.AC.IR Mashhad University of Medical Sciences Iran (Islamic Republic of) Men aged between 18 and 60 years old 35>BMI >25 Apparently healthy men Provision of written informed consent 18 years 60 years Male Professional athletes Current smoking habits History of cardiovascular diseases, hypertension, diabetes mellitus, hyperlipidemia, neurological and/or neuropsychological disorders, and renal disorders Using medications or supplements affecting energy and protein metabolism (e.g., thyroid drugs, Supplements containing L-carnitine, ephedrine, caffeine, and antidepressant drugs) Using protein supplements Using weight loss or weight gain supplements Using medications or supplements affecting appetite History of more than 10% change in body weight within the past 6 months Skipping breakfast regularly (having breakfast less than 5 times a week) Having dietary restrictions Trypanophobia (extreme fear of injections, hypodermic needles) or haemophobia (extreme fear of blood) E66 Overweight and obesity Other Other Intervention group: This group will receive an animal-based protein test meal. The test meal will provide 25% of the calculated total energy requirements and will consist of 30% protein (from animal sources), 40% carbohydrate, and 30% fat. This test meal consists of white bread, potatoes, sunflower oil, and egg, chicken, or yogurt (as the protein sources). The test meals will be prepared in the Nutrition Department kitchen at the Mashhad University of Medical Sciences, Mashhad, Iran. Chemical analysis will be performed on a sample of test meals to determine their macronutrient composition and amino acid profile. Intervention group: This group will receive a plant-based protein test meal. The test meal will provide 25% of the calculated total energy requirements and will consist of 30% protein (from plant sources), 40% carbohydrate, and 30% fat. This test meal will contain white bread, potatoes, sunflower oil, lentils, and soy (as the protein sources). The test meals will be prepared in the Nutrition Department kitchen at the Mashhad University of Medical Sciences, Mashhad, Iran. Chemical analysis will be performed on a sample of test meals to determine their macronutrient composition and amino acid profile. Respiratory quotient. Timepoint: In the fasting state and during 5 hours after test meal (1,3, and 5 hours after test meal). Method of measurement: Indirect calorimetry (Metalyzer 3B). Resting energy expenditure. Timepoint: In the fasting state and during 5 hours after test meal (1,3, and 5 hours after test meal). Method of measurement: Indirect calorimetry (Metalyzer 3B). Diet induced thermogenesis. Timepoint: In the fasting state and during 5 hours after test meal (1,3, and 5 hours after test meal). Method of measurement: Indirect calorimetry (Metalyzer 3B). Pulse wave velocity. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5 , and 5.5 hours after test meal). Method of measurement: Tonometry. Pulse wave analysis. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5 , and 5.5 hours after test meal). Method of measurement: Sphygmocor device. Appetite response. Timepoint: In the fasting state and during 5 hours after test meal (every 1 hour). Method of measurement: Visual analogue scales (VAS). Blood glucose level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic colorimetric method. Serum insulin level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Elisa method. Triglyceride level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic method. Total cholesterol level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic method. Low Density Lipoprotein- cholesterol level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic method. High Density Lipoprotein-Cholesterol (HDL-C) level. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic method. Serum free fatty acids. Timepoint: In the fasting state and during 5.5 hours after test meal (0.5, 1.5, 3.5, and 5.5 hours after test meal). Method of measurement: Enzymatic Colorimetric. Mashhad University of Medical Sciences Approved 2021-04-20 Ethics committee of Mashhad Univercity of Medical Sciences Nutrition Department,Medical School, Mashhad University of Medical Sciences, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)