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IRCT20180712040438N5 IRCT 2020-07-12 Kermanshah University of Medical Sciences The effect of dietary approaches to stop hypertension (DASH) diet on obesity DASHLOW Comparison of the effect of dietary approaches to stop hypertension (DASH) diet with regular hypocaloric diet on on anthropometric indices, expression of some micro RNAs and genes involved in metabolic, inflammatory and hormonal status in obese adults 2020-07-25 anticipated 120 Complete https://irct.ir/trial/49332 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method: First, the list of participants was provided according to their referral. Then all possible sequences that can be written with three groups, were written on paper (for 3 groups 12 sequences can be written). Then one of the numbers from 1 to 12 was considered for each sequence, for example for the ABC sequence 1 and for the ACB sequence 2 and as such, one of the numbers 3 to 6 was considered for the other 4 sequences. Then, using random number table, the random numbers were selected from one point to the left or right. Wherever the random number was 1 to 6, the corresponding sequence was recorded on the paper. This method continued until groups for the total number of participants were determined. Then, the names of subjects on the list were allocated to the specific groups according to the sequence of groups which had been determined by the above mentioned procedure, Blinding description: Participants, care giver and investigator are unaware of the differences in the incoming regimes. N/A Obesity. Intervention 1: Control group: They will use a diet based on the Iranian food pyramid and routine training that is normally provided by hospital nutrition experts. Intervention 2: Intervention group: Receiving hypocaloric diet. In this group, the required energy of each person will be determined based on Mifflin-St Jeor formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on a regular diet. Intervention 3: Intervention group: Receiving dietary approaches to stop hypertension diet (DASH) hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on DASH diet.DASH diet is rich in fruits, vegetables, whole grains, low-fat dairy foods and is limited in saturated fatty acids, total fat and cholesterol, refined cereals and sugar sweetened drinks with an overall 2400 mg per day sodium intake. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: he data of the present study will only be accessible by other researchers, for conducting Meta analysis Where to obtain: Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516766, j.moloudi@yahoo.com How to obtain: Any one who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All these steps will not take more than 10 days. Comments:
public Jalal Moludi
Isar St
Tabriz Iran (Islamic Republic of) 1236549875 +98 41 3335 2148 moludij@tbzmed.ac.ir Kermanshah University of Medical Sciences scientific Jalal Moludi
Isar St
Kermanshah Iran (Islamic Republic of) 32164547965 +98 41 3335 2148 moludij@tbzmed.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Body mass index 35-25 kg /m 2 Age range from 20 to 50 years old 20 years 50 years Both Patients with severe diseases Pregnancy Alcohol consumption E66 Overweight and obesity Placebo Treatment - Other Treatment - Other Control group: They will use a diet based on the Iranian food pyramid and routine training that is normally provided by hospital nutrition experts. Intervention group: Receiving hypocaloric diet. In this group, the required energy of each person will be determined based on Mifflin-St Jeor formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on a regular diet. Intervention group: Receiving dietary approaches to stop hypertension diet (DASH) hypocaloric diet. In this group, the required energy of each person will be determined based on Harris Benedict formula, the rate of 500 kcal will be deducted then units of each food groups will be determined based on DASH diet.DASH diet is rich in fruits, vegetables, whole grains, low-fat dairy foods and is limited in saturated fatty acids, total fat and cholesterol, refined cereals and sugar sweetened drinks with an overall 2400 mg per day sodium intake. Anthropometric indices. Timepoint: Baseline and End-of-trial. Method of measurement: Digital scale. Blood sugar. Timepoint: Baseline and End-of-trial. Method of measurement: Automatic clinical chemical analysis device. Lipid profile including TG, HDL-C, and TC. Timepoint: Baseline and End-of-trial. Method of measurement: Automatic clinical chemical analysis device. Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Insulin. Adipokines levels include spixin, leptin, and adiponectin. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: ElISA. Interleukin 6 and 10. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: ElISA. Hs-CRP. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: ElISA. Expression of micro RNA 122a, mir15, mir155a, mir 146, mir 193. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: RT-PCR. PPARg Expression. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: RT-PCR. FTO Expression. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: RT-PCR. Bile acid (BA) profiles. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: Elisa. LPS. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: ElISA. Trimethylamine N-oxide. Timepoint: At the beginning of the study (before intervention) and three months after the beginning of the intervention. Method of measurement: ElISA. Kermanshah University of Medical Sciences Approved 2020-06-16 Ethics Committee of Kermanshah University of Medical Sciences Faculty of Nutrition and Food Technology, Next to Farabi Hospital, Kermanshah, Iran , Postcode: 6719851552 Kermanshah Kermanshah Iran (Islamic Republic of)