Irct20150909023957N8.

Study name	Effect of low‐calorie diets on anthropometric indices, glycemic markers and cardiovascular risk factors in metabolic syndrome
Methods	Randomised controlled trial
Participants	Inclusion criteria 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 Ppeople who are willing to cooperate and answer questions and conduct their tests after explaining the work Exclusion criteria 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
Interventions	Intervention 1: During 8‐week ADF period, participants 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 participants consume ad libitum without limitation. ADF participants 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 participant was undergoing the same duration of fasting. all food prepared in the home. Participants 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, participants consumed 75% energy needs in each day for 8 weeks and includes 3 main meals and 2 snacks. All participants 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.
Outcomes	Primary Outcomes BMI. Timepoint: two times, before and after dietary intervention. Method of measurement: BMI was calculated as the weight in kg divided by the square of the height in meters (kg/m2). 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 analyser (BIA; BC‐418, Tanita Europe, Amsterdam, NL). Fasting blood sugar. Timepoint: two times, before and after dietary intervention. Method of measurement: fasting plasma glucose concentrations were measured using auto‐analyser (glucose oxidase/peroxidase). HDL cholesterol. Timepoint: two times, before and after dietary intervention. Method of measurement: Plasma HDL‐C was measured using detergent oxidase/peroxidase methods. HOMA‐IR. Timepoint: Two times, before and after dietary intervention. Method of measurement: fasting glucose (mmol/L) * fasting insulin (µU/L)/ 22.5. 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). Plasma insulin. Timepoint: two times, before and after dietary intervention. Method of measurement: plasma insulin levels were measured by Elisa 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. Triglyceride (TG). Timepoint: two times, before and after dietary intervention. Method of measurement: plasma TG concentration was measured glycerol phosphate oxidase/peroxidase method. 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 participant 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.
Starting date	2019‐01‐23
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