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IRCT20150909023957N8 IRCT 2019-01-23 Vice Chancellor for Research, Isfahan university of medical sciences Effect of low-calorie diets on anthropometric indices, glycemic markers and cardiovascular risk factors in metabolic syndrome Effect of modified Alternate-Day Fasting (ADF) in contrast with Calorie Restriction (CR) on anthropometric indices, glycemic markers and cardiovascular risk factors in metabolic syndrome patients. 2017-07-06 anticipated 70 Complete https://irct.ir/trial/20340 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All participants were stratified for body mass index (BMI), age and sex, and were randomly assigned to ADF or CR group for 8 weeks. Randomization was performed using by random- generation software. N/A metabolic syndrome disease. Intervention 1: During 8-week ADF period, subjects consumed very low calorie diet (75% energy restriction) during the 3 fast days (Saturday, Monday, Wednesday) and then ate diet that providing 100% of their energy needs on each feed day (3 days a week). In Friday subjects consume ad libitum without limitation. ADF subjects were provided with meals on each fast day (ranging from 400- 600 kcal), and consumed ad libitum at home on feed day. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting. all food prepared in the home. Subjects were permitted to consume calorie- free foods (such as water, green tea, coffee without sugar (< 400 mg caffeine per day), non-starchy vegetable (such as lettuce, cucumber, green leaf, tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water. Intervention 2: Control group: In Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively. 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 There is no further information
public arefe parvaresh
Hezar Jarib Avenue, Isafahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
Isfehan Iran (Islamic Republic of) 8174673461 +98 35 3726 2557 a.p.nutrition86@gmail.com Isfehan university of medical science scientific Noushin Mohammadifard
Hezar Jarib Avenue, Isfahan University of Medical Sciences, School of Nutrition and Food Science, Isfahan
isfahan Iran (Islamic Republic of) 8174673461 +98 31 3337 7883 nmohammadifard@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with Metabolic Syndrome Age 25-60 years 25 ≤BMI ≤40 kg/m2 Body weight more than 5 kg has not changed during the last 3 months. No fasting for 3 months prior to the beginning of the study People who are willing to cooperate and answer questions and conduct their tests after explaining the work. 25 years 60 years Both Smoker History of cardiovascular, pulmonary, renal, thyroid disorders, digestive and liver problems such as hepatitis and ... Follow a special diet Severe physical activity People who have been using drugs that have an effect on weight loss, lipid or glucose metabolism over the past 6 months. E88.81 Metabolic syndrome Lifestyle Lifestyle During 8-week ADF period, subjects consumed very low calorie diet (75% energy restriction) during the 3 fast days (Saturday, Monday, Wednesday) and then ate diet that providing 100% of their energy needs on each feed day (3 days a week). In Friday subjects consume ad libitum without limitation. ADF subjects were provided with meals on each fast day (ranging from 400- 600 kcal), and consumed ad libitum at home on feed day. The feed and fast days began at midnight each day, and all fast day meals were consumed between 12.00 pm and 2.00 pm to ensure that each subject was undergoing the same duration of fasting. all food prepared in the home. Subjects were permitted to consume calorie- free foods (such as water, green tea, coffee without sugar (< 400 mg caffeine per day), non-starchy vegetable (such as lettuce, cucumber, green leaf, tomato) and sugar free gums on the fast day and were encouraged to drink plenty of water. Control group: In Calorie Restriction group, subjects consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All subjects in two groups were required to prepare all of their meals at home. The baseline energy requirements for the subjects were assessed by Mifflin equation. Daily dietary carbohydrate, fat and protein accounted for 52, 30 and 18% of ingested energy, respectively. Body weight and body composition analysis. Timepoint: Two times, before and after dietary intervention. Method of measurement: In light clothing, standing without shoes and hose on metal foot- plates while holding the handles of the bio-impedance analyzer (BIA; BC-418, Tanita Europe, Amsterdam, NL). BMI. Timepoint: Two times, before and after dietary intervention. Method of measurement: BMI was calculated as the weight in kilograms divided by the square of the height in meters (kg/m2). Waist circumference. Timepoint: Two times, before and after dietary intervention. Method of measurement: Waist circumference was measured by a flexible tape to the nearest 0.1 cm, in standing subject at the midway between the lower costal margin of the last palpable rib and the top of the iliac crest during a period of expiration. Triglyceride (TG). Timepoint: Two times, before and after dietary intervention. Method of measurement: Plasma TG concentration was measured glycerol phosphate oxidase/peroxidase method. Total cholesterol. Timepoint: Two times, before and after dietary intervention. Method of measurement: Plasma total cholesterol was measured in duplicate using cholesterol oxidase/peroxidase. HDL cholesterol. Timepoint: Two times, before and after dietary intervention. Method of measurement: Plasma HDL-C were measured Detergent oxidase/peroxidase methods. LDL cholesterol. Timepoint: Two times, before and after dietary intervention. Method of measurement: LDL-C concentration was calculated using the Friedwald equation (LDL= total cholesterol – TAG/ 2.18 – HDL). Fasting blood sugar. Timepoint: Two times, before and after dietary intervention. Method of measurement: Fasting plasma glucose concentrations were measured using auto-analyzer (glucose oxidase/peroxidase). Plasma insulin. Timepoint: Two times, before and after dietary intervention. Method of measurement: Plasma insulin levels were measured by Elisa method. HOMA-IR. Timepoint: Two times, before and after dietary intervention. Method of measurement: fasting glucose (mmol/L) * fasting insulin (μU/L)/ 22.5. Vice Chancellor for Research, Isfahan university of medical sciences Approved 2015-06-05 Ethics committee of Isfahan university of medical sciences isfahan, hezar jerib street, Isfahan univercity of medical science Isfahan Isfehan Iran (Islamic Republic of)