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IRCT20190717044244N1 IRCT 2019-08-19 Ahvaz University of Medical Sciences Fasting mimicking diet compared with low calorie diet among premenopausal obese women The effects of fasting mimicking diet versus low calorie diet on anthropometric measurements, body composition, insulin sensitivity and regulatory hormones of food intake on premenopausal obese women 2019-08-21 anticipated 60 Complete https://irct.ir/trial/40881 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: As the study is a diet intervention trial, it is not possible to blind the personnel. However, study personnel involved in data collection and specimen analysis will be blinded to group assignments, Randomization description: Patients will randomly assigned to the 2 groups. Every patient will receive a code number. The the codes were written on concealed letters and will be chosen by a second person and assign randomly to one of the study groups. N/A obesity. Intervention 1: Intervention group: fasting mimicking diet will be administered during the first 5 days of a month (In total, 2 five-days cycles for 2 months). Fasting mimicking diet is a plant-based diet providing both micro- and macro- nutrients to decrease side-effects of fasting. It consists of a total of 1099 kcal (11% protein, 46% fat, 43% carbohydrate) in the first day, and a total of 717 kcal (9% protein, 44% fat, 47% carbohydrate) in the 4 following days. This will be provided by semi-prepared soups form Mahram and Elit companies. Also, a multi vitamin mineral from Supplex company and an omega3 supplement from Eurovital company will be provided during the 5 days of the cycle. Participants should continue their usual diet during the other 25 days of a month. Intervention 2: Control group: Calorie deficit of 500 kcal for 2 months. the diet will be a Mediterranean diet with 30-35% fat, 20% protein, and 45-50% carbohydrate (mostly from whole grains) emphasizing on vegetables, fruits, cereals, fish, poultry, nuts, olive oil, and limiting processed meats, red meats, and sweets. 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 we can send data (after getting approval from the study PI) but it should be remained confidential. We are not allowed to publish data publically online.
public Mehdi Sadeghian
Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8253 mehdisad69@gmail.com Ahvaz University of Medical Sciences scientific Mehdi Sadeghian
Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8253 mehdisad69@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) healthy women aged 18-50 years BMI ranged from 30 to 35 not to use any tobacco regular menstrual cycle not to have symptoms of hyperandrogenism or PCOS not to use contraceptive drugs negative pregnancy test not having metabolic disorder affecting gluconeogenesis not having medical history of heart diseases not having considerable food allergies weight change less than 3 kg in the last 3 months not having psychotic disorder affecting the patients' adherence 18 years 55 years Female not to have adherence to the diet unwilling to continue the trial E66 Overweight and obesity Lifestyle Lifestyle Intervention group: fasting mimicking diet will be administered during the first 5 days of a month (In total, 2 five-days cycles for 2 months). Fasting mimicking diet is a plant-based diet providing both micro- and macro- nutrients to decrease side-effects of fasting. It consists of a total of 1099 kcal (11% protein, 46% fat, 43% carbohydrate) in the first day, and a total of 717 kcal (9% protein, 44% fat, 47% carbohydrate) in the 4 following days. This will be provided by semi-prepared soups form Mahram and Elit companies. Also, a multi vitamin mineral from Supplex company and an omega3 supplement from Eurovital company will be provided during the 5 days of the cycle. Participants should continue their usual diet during the other 25 days of a month. Control group: Calorie deficit of 500 kcal for 2 months. the diet will be a Mediterranean diet with 30-35% fat, 20% protein, and 45-50% carbohydrate (mostly from whole grains) emphasizing on vegetables, fruits, cereals, fish, poultry, nuts, olive oil, and limiting processed meats, red meats, and sweets. Body weight. Timepoint: Body weight will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: digital scale. Body fat mass. Timepoint: Body fat mass will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: Body composition analyzer. Fat free mass. Timepoint: Fat free mass will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: Body composition analyzer. Serum glucose. Timepoint: Serum glucose will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: enzymatic methods. Serum insulin. Timepoint: Serum glucose will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: ELISA. Ghrelin. Timepoint: Serum ghrelin will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: ELISA. Leptin. Timepoint: Serum leptin will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: ELISA. Neuropeptide Y. Timepoint: Serum neuropeptide Y will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: ELISA. Waist circumference. Timepoint: Waist circumference will be measured just before the inclusion in the trial and at the end of the intervention (after 2 months). Method of measurement: Meter. Ahvaz University of Medical Sciences Approved 2019-03-12 Ahvaz Jundishapur University of Medical Sciences golestan ahvaz Khouzestan Iran (Islamic Republic of)