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IRCT20201102049229N1 IRCT 2020-12-19 Tehran University of Medical Sciences The effect of high consumption of dairy on women's weight loss Exploring the effect of high consumption of dairy products in a high-protein diet combined with aerobic exercise and calorie restriction on weight loss and central obesity reduction in overweight women 2021-04-04 anticipated 60 Complete https://irct.ir/trial/52229 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization based on a single sequence of random allocations is called simple randomization. In this study, simple randomization is used. Individuals are randomly assigned to one of the two study groups using the table of random numbers and receive the intervention of the same group. Accidental concealment will be conducted by a second person who does not participate in other stages of the intervention, Blinding description: The evaluator of the results will be blind. The measurement and analysis, which are carried out two weeks after the diet, will be conducted by this person. N/A Overweight. Intervention 1: Intervention group: the group on a high-protein and high level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. For this group, a diet of high protein and calcium (1.5 grams of protein per kilogram of body weight) with dairy sources (milk-casein) and 700 kcal restriction per day is prescribed as needed. Moreover, aerobic exercise with medium intensity is prescribed (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again. Intervention 2: Control group: the group on a high-protein but moderate level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. Aerobic exercise with medium intensity is aslo prescribed for this group (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Zahra Alizadeh
No. 7, Sports Medicine Research Center, Opposite of Shariati Hospital, Jalal Al-Ahmad Highway
Tehran Iran (Islamic Republic of) 57814395 +98 21 6119 2282 z_alizadeh@tums.ac.ir Tehran University of Medical Sciences scientific Zahra Alizadeh
No. 7, Sports Medicine Research Center, the opposite of Shariati Hospital, Jalal Al-Ahmad Highway
Tehran Iran (Islamic Republic of) 57814395 +98 21 6119 2282 z_alizadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Individuals with BMI between 25 and 29.9 Individuals aged between 20 and 45 years No history of disease (uncontrolled diabetes, severe cardiovascular disease, musculoskeletal limitations and exercise-limiting neurological disorders, uncontrolled blood pressure, chronic obstructive pulmonary disease, migraine, kidney disease, taking any medication that affects a person's weight, appetite, heart rate or ability to do physical exercise 20 years 45 years Female Lactose intolerance and sensitivity to dairy protein The presence of a metal device or heart pacemaker in the body Pregnancy Musculoskeletal problems and exercise-limiting neurological disorders that prevent the continuation of physical activity Weight-loss medications such as appetite suppressants Reluctance to cooperate E66 Overweight and obesity Prevention Prevention Intervention group: the group on a high-protein and high level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. For this group, a diet of high protein and calcium (1.5 grams of protein per kilogram of body weight) with dairy sources (milk-casein) and 700 kcal restriction per day is prescribed as needed. Moreover, aerobic exercise with medium intensity is prescribed (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again. Control group: the group on a high-protein but moderate level of dairy diet and daily calorie restriction of 700 Kcal combined with medium intensity of aerobic exercise. Aerobic exercise with medium intensity is aslo prescribed for this group (including jogging or running on treadmill 3 to 5 days a week for 2 weeks). Patients are given a logbook to record exercise, and a weekly food reminder is requested from the patient. After 2 weeks, the analysis is undertaken again. Weight loss. Timepoint: At the beginning of the study and two weeks later. Method of measurement: Weight measurement by compartment body composition analyzer. Central obesity reduction. Timepoint: At the beginning of the study and two weeks later. Method of measurement: Measuring waist circumference, skin folds, and supra-iliac. Body composition. Timepoint: At the beginning of the study and two weeks after that. Method of measurement: Compartment body composition analyzer AVIS334. Tehran University of Medical Sciences Approved 2020-10-20 Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)