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IRCT20090822002365N24 IRCT 2020-01-15 Vice chancellor for research, Iran University of Medical Sciences The effect of Gut Makeover diet with or without yoga on weight management Effect of the Gut Makeover diet with or without yoga on weight management in obese women with food addiction 2020-04-03 anticipated 136 Complete https://irct.ir/trial/44579 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sample of the study included women working in colleges and medical centers affiliated to Iran University of Medical Sciences and Shahid Beheshti University of Medical Sciences. With a sample size of 136 people, 34 blocks of 4 will be produced using the online site (www.sealedenvelope.com) and participants will be assigned to one of four study intervention groups. N/A Obesity. Intervention 1: Intervention group 1: The group receiving a calorie restricted diet in the GM diet ( a restriction of 500 calories less than their energy intake in the GM diet), for 8 weeks. The GM diet is divided into two 4-week phases and each phase is as follows: During the first 4 weeks, people are advised to: - Get three main meals a day without a snack. - The 12-hour meal period between dinner and breakfast. During this time, people are fasting and only allowed to drink water.- Eat 5 units of vegetables and 2 units of fruit group daily.- At each meal, receive a rich source of protein (animal source such as fish, eggs, Or nuts and seeds) .- Eat between 20 and 30 different types of plant sources (fresh edible plants, fruits, vegetables) each week. - Use olive oil and coconut oil as baking oil. - Chewing the food thoroughly in the mouth so that each bite is chewed 20 times in your mouth. - Do not calculate and limit your intake of calories. People are also recommended during the next 4 weeks: - can get ghee in a permissible amount. - Eat foods containing probiotic such as fermented milk (kefir) and increase intake of prebiotic-containing vegetables such as bananas, fennel, onions, garlic, and leeks. Also, during the next 4 weeks, participants must remove the following sources from their daily diet: - refined sugar, grains (such as wheat, rice, barley) and legumes (such as beans and lentils), caffeine, dairy (can be put on a diet after two weeks if it has no side effects). Two weeks before starting the GM diet participants are advised to remove all probiotic-containing products from their daily diet. Also, other types of probiotic-containing foods should be excluded from their diet during the study. Intervention 2: Intervention group 2: Calorie restriction (500 calories less than energy need per person) with yoga. Yoga therapy: The intervention program includes asanas, pranayama, and relaxation strategies that will be held 3 sessions per week. These meetings will not be ongoing for the better recovery of the participants. The exercise program will also be determined based on issues including overload, repetition, intensity, timing, and type of exercise. In this study, yoga training courses and movement levels are increased each week based on the ability of the participants. Finally, it will reach 75 minutes in the final week. Intervention 3: Intervention group 3: Restriction of calorie intake (500 calories less than the energy they need) in GM diet with yoga therapy. Intervention 4: Control group: During the study, subjects in the control group will received a daily restricted diet (500 calories less than the energy they need.). Yes - There is a plan to make this available What will be shared: A part of the data will be shared, such as primary outcomes. When: Four months after the publication of the results. To whom: Researchers and students of university Conditions: Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis. Where to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com How to obtain: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com Comments:
public Mohammad Reza Vafa
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad reza Vafa
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 vafa.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Obese women with 18-50 years old BMI: 30-40 kg/m2 Food addiction based on YFAS questionnaire Lack of gout and chronic diseases such as diabetes, cardiovascular, liver, etc. Not taking drugs that affect appetite and weight No use of antibiotics in the last three weeks Not taking vitamin supplements and minerals Not following a specific diet No weight loss of 3 kg or more during the past 2 months No psychiatric illness Not being pregnant or breast-feeding Have a regular menstrual cycle No food allergies Willingness to participate in the study 18 years 50 years Female Having any acute illness Pregnancy during the study period Failure to follow the intervention Immigration Exclusion from the study based on participants' personal preference E66.0 Obesity due to excess calories Lifestyle Lifestyle Lifestyle Lifestyle Intervention group 1: The group receiving a calorie restricted diet in the GM diet ( a restriction of 500 calories less than their energy intake in the GM diet), for 8 weeks. The GM diet is divided into two 4-week phases and each phase is as follows: During the first 4 weeks, people are advised to: - Get three main meals a day without a snack. - The 12-hour meal period between dinner and breakfast. During this time, people are fasting and only allowed to drink water.- Eat 5 units of vegetables and 2 units of fruit group daily.- At each meal, receive a rich source of protein (animal source such as fish, eggs, Or nuts and seeds) .- Eat between 20 and 30 different types of plant sources (fresh edible plants, fruits, vegetables) each week. - Use olive oil and coconut oil as baking oil. - Chewing the food thoroughly in the mouth so that each bite is chewed 20 times in your mouth. - Do not calculate and limit your intake of calories. People are also recommended during the next 4 weeks: - can get ghee in a permissible amount. - Eat foods containing probiotic such as fermented milk (kefir) and increase intake of prebiotic-containing vegetables such as bananas, fennel, onions, garlic, and leeks. Also, during the next 4 weeks, participants must remove the following sources from their daily diet: - refined sugar, grains (such as wheat, rice, barley) and legumes (such as beans and lentils), caffeine, dairy (can be put on a diet after two weeks if it has no side effects). Two weeks before starting the GM diet participants are advised to remove all probiotic-containing products from their daily diet. Also, other types of probiotic-containing foods should be excluded from their diet during the study. Intervention group 2: Calorie restriction (500 calories less than energy need per person) with yoga. Yoga therapy: The intervention program includes asanas, pranayama, and relaxation strategies that will be held 3 sessions per week. These meetings will not be ongoing for the better recovery of the participants. The exercise program will also be determined based on issues including overload, repetition, intensity, timing, and type of exercise. In this study, yoga training courses and movement levels are increased each week based on the ability of the participants. Finally, it will reach 75 minutes in the final week. Intervention group 3: Restriction of calorie intake (500 calories less than the energy they need) in GM diet with yoga therapy Control group: During the study, subjects in the control group will received a daily restricted diet (500 calories less than the energy they need.) Weight changes. Timepoint: Weight changes was measured at baseline (before intervention) and at the end of week 8. Method of measurement: Obesity status will be assessed by anthropometric indices (weight, body mass index, waist, hip circumference and waist to hip ratio) and body composition indices (body fat percentage, body fat free mass percentage, body fat weight, fat free mass, visceral fat percentage, visceral fat content in kg). Plasma Serotonin Concentration. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: The measurements will be performed by ZellBio kit (Made in Germany) by ELISA method. Plasma Oxytocin Concentration. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: The measurements will be performed by ZellBio kit (Made in Germany) by ELISA method. BDNF plasma concentration. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: It will be measured by Kate ZellBio (Made in Germany) ELISA method. Appetite. Timepoint: At baseline and after intervention (end of week 8). Method of measurement: People's appetite will also be measured using the standardized Simplified Nutritional Appetite Questionnaire (SNAQ). Food addiction rate. Timepoint: At baseline and after intervention (end of week 8). Method of measurement: Food addiction assessment will be performed by Yale Food Addiction Questionnaire (YFAS). Stress level. Timepoint: At baseline and after intervention (end of week 8). Method of measurement: People's stress levels will be assessed by a 14-item Cognitive Stress Scale. Vice chancellor for research, Iran University of Medical Sciences Approved 2019-12-15 Ethics committee of Iran University of Medical Sciences Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)