Protocol summary
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Study aim
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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
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Design
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Randomized clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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The intervention group will receive the DASH diet.
The control group will receive a standard diet.
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Main outcome variables
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Components of Metabolic syndrome including Waist circumference (WC); High density lipoprotein-cholesterol (HDL-c); Blood triglycerides (TG); Blood pressure; Fasting plasma glucose (FPG).
General information
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Reason for update
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We added new secondary outcomes. In addition, we reported actual recruitment start and end dates.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180201038585N12
Registration date:
2022-10-21, 1401/07/29
Registration timing:
prospective
Last update:
2022-12-23, 1401/10/02
Update count:
1
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Registration date
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2022-10-21, 1401/07/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-22, 1401/07/30
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Expected recruitment end date
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2023-01-20, 1401/10/30
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Actual recruitment start date
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2022-10-22, 1401/07/30
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Actual recruitment end date
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2022-11-21, 1401/08/30
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Trial completion date
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empty
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Scientific title
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The effect of dietary approaches to stop hypertension (DASH) diet on metabolic syndrome components and hepatic steatosis indices in subjects with metabolic syndrome
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Public title
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The effect of DASH diet in subjects with metabolic syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 30-60 years
Diagnosis of Metabolic Syndrome based on IDF criteria
Sign of informed written consent
Exclusion criteria:
Pregnancy and lactation
Hereditary hemochromatosis
History of gingival or gastroplasty bypass surgery
Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens
Patients with hypothyroidism
Cushing syndrome
Kidney failure and kidney stone
Cardiovascular disease
History of hepatitis B and C
Wilson disease
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-05-21, 1401/02/31
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1401.016
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
Primary outcomes
1
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Description
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Diastolic Blood Pressure
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Sphygmomanometer
Secondary outcomes
1
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Description
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Waist Circumference
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Meter
2
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Description
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Triglyceride
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
3
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Description
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High density lipoprotein cholesterol
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
4
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Description
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Systolic blood pressure
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Sphygmomanometer
5
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Description
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Fasting blood glucose
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
6
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Description
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Low density lipoprotein cholesterol
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
7
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Description
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Total Cholesterol
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
8
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Description
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Alanine Aminotransferase
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
9
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Description
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Aspartat transaminase
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
10
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Description
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Weight
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Scale
11
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Description
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Body mass index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
12
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Description
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Hepatic steatosis index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
13
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Description
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Lipid accumulation product
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
14
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Description
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Visceral adiposity index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
15
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Description
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Fatty liver index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
16
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Description
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Gamma-glutamyl transpeptidase
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Enzymatic method
17
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Description
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Atherogenix index of plasma
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
18
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Description
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Atherogenic coefficient
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
19
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Description
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Castelli risk index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
20
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Description
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Cardiometabolic index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
21
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Description
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TyG index
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
22
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Description
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Metabolic score for insulin resistance
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Timepoint
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Before intervention and 12 weeks after the intervention
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Method of measurement
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Formula
Intervention groups
1
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Description
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Intervention group: The intervention group will receive DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person.
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Category
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Lifestyle
2
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Description
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Control group: The control group will receive a standard diet. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. 500 kcal for those with a BMI in the range of 25-31 kg/m2 and 700 kcal for those with a BMI more than 31 kg/m2 will be deducted from the total energy required by each person.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable