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

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

The controlled clinical trial with 3 parallel groups (40 in each group), double blinded, randomized by random number table method

The number of 120 (40 in each group) eligible patients having BMI more than 30 will be selected.Then the subjects will be divided into three groups by permuted block randomization.The three groups include: usual dietary recommendations, Hypocaloric diet, and DASH + Hypocaloric diet. The diet will be written to each individual. In this way, the required energy will be calculated based on Mifflin-St Jeor formula, In Group 1 the receiving diet including usual dietary recommendations without deduction of energy units. In Group 2 and 3 the rate of 500 kcal will be deducted, then units of each food groups will be determined based on a regular diet in group 2 and DASH diet in group 3. After 3 months of intervention, all groups will be compared.

Inclusion criteria:: patients have BMI more than 30 and willing to participate in the study. Exclusion criteria: cardiovascular disease, liver disease, chronic diseases such as cancer, kidney failure; pregnancy; lactation; having certain diets like vegetarian and raw veganism; alcohol consumption.

The subjects divide into 3 groups, Group 1: receiving diet including usual dietary recommendations. Group 2: receiving hypocaloric diet. Group 3: receiving hypocaloric DASH diet

anthropometric indices; expression of some micro RNAs and genes involved in metabolic; inflammatory and hormonal status

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.

Participants, care giver and investigator are unaware of the differences in the incoming regimes.

Data collected for the primary outcomes will be shared

Accessibility to data is possible 8 months after publication.

The data will only be available for people working in academic institutions.

he data of the present study will only be accessible by other researchers, for conducting Meta analysis

Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516766, j.moloudi@yahoo.com

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.