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IRCT20220101053579N1 IRCT 2022-01-12 Mashhad University of Medical Sciences Effect of beetroot extract on cardiovascular factors in men with metabolic syndrome Evaluation of the effect of non-organic nitrate supplementation on macro-and micro-vascular changes in active and inactive men with metabolic syndrome 2022-05-22 anticipated 60 Complete https://irct.ir/trial/60994 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed based on stratified block randomization. Block size would be 8 and participants will be randomized into each block based on age (below 30, 30 or above), BMI (below 30 kg/m2, 30 kg/m2 or over), and presence of elevated blood pressure (below 130/85 mmHg, 130/85 mmHg or over). Randomization concealment will be performed using sealed envelops. One of the research team members will perform the concealment based on the randomization list. Envelops will be opaque and sealed so that other researchers and the participants will not be aware of their group allocation. 3 Metabolic syndrome. Intervention 1: Intervention group 1: Physical activity intervention will be conducted using low volume high intensity interval training method. Due to the COVID-19 pandemic, instructions will be provided to the participants and the participants will perform the exercises at home after ensuring their mastery on the methods. Intensity of the exercises will be defined based on primary evaluations of perceived exertion, heart rate at 65% and 85% of VO2 Max. Exercises will be conducted in the form of two repetitions of four sets of high intensity intermittent exercises, which are composed of a training phase and a rest phase. Training phase will last for 2 minutes. Participants should keep their heart rate above 85% of VO2Max during the training phase. Then, participants will continue the training phase exercise at a lower intensity (65% of VO2Max). Active rest can be conducted in the form of walking or jogging in place. Duration of the physical activity intervention will be 66 minutes per week. In order to ensure that the participants perform exercises in the correct way, a software that includes video and textual instructions on each exercise is designed and provided to the participants. The software sends twice weekly messages to the participants based on their progress. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Intervention 2: Intervention group 2: Beetroot extract will be administered at 30% ADI equal to 3.7 mg/kg/d as two divided doses consumed twice weekly for 4 weeks. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Intervention 3: Intervention group 3: This group will receive both the mentioned physical activity and beetroot extract interventions all together. The intervention duration will be 4 weeks. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Intervention 4: Control group: The control group will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate and following an active lifestyle. The control group will not receive placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is Persian cohort center will provide the data to researchers in a case-by-case basis and the center has the complete ownership of the data.
public Ali Jafarzadeh Esfehani
East door of Ferdowsi University, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 JafarzadehEA982@mums.ac.ir Mashhad University of Medical Sciences scientific Mohsen Nemati
School of Medicine, East door of Ferdowsi University, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 NematyM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study by signing an informed consent Age between 18 and 40 years old Diagnosis of metabolic syndrome based on the International Diabetes Federation (IDF) criteria Low to moderate level of physical activity based on the International Physical Activity Questionnaire (IPAQ) No history for chronic diseases (Diabetes Mellitus, heart failure) No history for Rheumatologic or joint disorders that impair the ability of performing exercises No history for underlying diseases that may affect metabolic syndrome (Cushing syndrome, Addison's disease) No history for hypertension, diabetes and dyslipidemia Male gender 18 years 40 years Male Using medications that affect metabolic syndrome (chemotherapy, corticosteroids) Cancer Physical disability that prevents performing the exrcises Mental or psychological disorders that prevent performing the study protocol E88.81 Metabolic syndrome Lifestyle Other Lifestyle N/A Intervention group 1: Physical activity intervention will be conducted using low volume high intensity interval training method. Due to the COVID-19 pandemic, instructions will be provided to the participants and the participants will perform the exercises at home after ensuring their mastery on the methods. Intensity of the exercises will be defined based on primary evaluations of perceived exertion, heart rate at 65% and 85% of VO2 Max. Exercises will be conducted in the form of two repetitions of four sets of high intensity intermittent exercises, which are composed of a training phase and a rest phase. Training phase will last for 2 minutes. Participants should keep their heart rate above 85% of VO2Max during the training phase. Then, participants will continue the training phase exercise at a lower intensity (65% of VO2Max). Active rest can be conducted in the form of walking or jogging in place. Duration of the physical activity intervention will be 66 minutes per week. In order to ensure that the participants perform exercises in the correct way, a software that includes video and textual instructions on each exercise is designed and provided to the participants. The software sends twice weekly messages to the participants based on their progress. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Intervention group 2: Beetroot extract will be administered at 30% ADI equal to 3.7 mg/kg/d as two divided doses consumed twice weekly for 4 weeks. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Intervention group 3: This group will receive both the mentioned physical activity and beetroot extract interventions all together. The intervention duration will be 4 weeks. Participants will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate intake. Control group: The control group will receive general dietary advice (300 Cal deficit per day) and limit dietary nitrate and following an active lifestyle. The control group will not receive placebo. Mean pulse wave velocity. Timepoint: Baseline and the end of study (4th week). Method of measurement: PWV at the bifurcation of carotid artery using Doppler ultrasound. Augmentation index (AI). Timepoint: Baseline and the end of study (4th week). Method of measurement: PWV using Doppler ultrasound. Avascular area. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Increase in the diameter of the capillaries. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Microhaemorrhage. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Hairpin structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Tortuous structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Crossing structures. Timepoint: Baseline and the end of study (4th week). Method of measurement: Nail fold capillaroscopy. Fasting blood sugar. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample. Total cholesterol. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample. Serum triglyceride. Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample. Low-density lipoprotein (LDL). Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample. High density lipoprotein (HDL). Timepoint: Baseline and at the end of the study. Method of measurement: Biochemical analysis of blood sample. Serum nitrate. Timepoint: Weekly from the beginning of the study. Method of measurement: Measuring serum nitrate using nitrate kit. Step test. Timepoint: Baseline and at the end of the study. Method of measurement: Measured using a standard step. Systolic blood pressure. Timepoint: Weekly from the beginning of the study. Method of measurement: Measured using sphygmomanometer. Diastolic blood pressure. Timepoint: Weekly from the beginning of the study. Method of measurement: Measured using sphygmomanometer. VO2Max. Timepoint: Baseline, second week, and at the end of the study. Method of measurement: Measured on treadmill using CPET device. Dietary intake. Timepoint: Weekly from the beginning of the study. Method of measurement: 3-day 24-hour recall. Mashhad University of Medical Sciences Approved 2021-12-11 Ethics Committee of the Mashhad University of Medical Scineces School of Medicine, East door of Ferdowsi University, Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)