The effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome

Evaluation of the effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome

Randomized clinical trial

This 12-week study is a randomized controlled clinical trial that will investigate the effect of the DASH diet on the components of metabolic syndrome and indices of hepatic steatosis in subjects with metabolic syndrome with metabolic syndrome based on IDF criteria in Yazd city. Participation in the study is completely free and is managed by investigator who explainthe study process, goals, benefits and limitations and obtaining written consent with the participant's signature. Then, by examining other inclusion criteria for entering the study, the subjects are selected to start the intervention. Participants will be divided into intervention group or control group by a computer-generated random numbers table using a stratified randomization process based on gender and age.

Inclusion criteria: age 30-60 years old, Diagnosis of metabolic syndrome based on IDF criteria, Sign of informed written consent. Exclusion criteria: 1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Cushing syndrome 7.Kidney failure and kidney stones 8. Cardiovascular disease 9. History of hepatitis B and C 10. Wilson disease

The intervention group will receive the DASH diet. The control group will receive a standard diet.

Components of Metabolic syndrome including Waist circumference (WC); High density lipoprotein-cholesterol (HDL-c); Blood triglycerides (TG); Blood pressure; Fasting plasma glucose (FPG).

We added new secondary outcomes. In addition, we reported actual recruitment start and end dates.

Participants will be divided into intervention group or control group utilizing a random allocation software by a third trained person. A computer-generated random numbers table, presented by Saghaei in 2004, will be used to generate the random sequence. Baseline characteristics of the participants such as gender and age will be determined and recorded before random allocation. Then, using a stratified randomization process based on gender (male/female) and age (30–45 and 45–60 years) the participants will be divided into intervention group or control group. Allocation concealment will be conducted using opaque sealed envelopes to prevent selection bias by concealing the allocation sequence from those assigning participants to the intervention groups.