Protocol summary
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Study aim
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The aim of this study is to determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome (PCOS).
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Design
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Study design: parallel single-blind randomized controlled clinical trial.
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Settings and conduct
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Among patients with PCOS referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 108 patients will be selected according to inclusion and exclusion criteria. Participants are unaware of the study groups. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion and Exclusion Criteria: Women aged 18-40 years with overweight and obese diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study.
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Intervention groups
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Intervention: Patients will be assigned to receive either the DASH diet (intervention group 1: n=27) or the standard diet (control group 1: n=27) and the DASH diet (intervention group 2: n=27) or the standard diet (control group 2: n=27).
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Main outcome variables
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Outcomes: Hs-CRP and LDL-cholesterol (primary outcomes) and glycemic control, other lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201304235623N6
Registration date:
2013-05-04, 1392/02/14
Registration timing:
registered_while_recruiting
Last update:
2019-08-11, 1398/05/20
Update count:
1
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Registration date
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2013-05-04, 1392/02/14
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2013-04-23, 1392/02/03
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Expected recruitment end date
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2013-06-18, 1392/03/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of the hypocaloric DASH diet on metabolic parameters, inflammatory factor and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome
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Public title
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Effect of diet therapy in treatment of polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 18-40 years
Diagnosed with PCOS
Exclusion criteria:
Individuals with neoplastic
Cardiovascular disorders
Malabsorptive disorders
Current or previous (within the last 6 months) use of hormonal
Antidiabetic medications
Anti-obesity medications
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, patients were randomly allocated into two groups to take either DASH diet or control. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants are unaware of the study groups.
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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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2013-04-23, 1392/02/03
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Ethics committee reference number
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P/29/5/1/9213
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Sclerocystic ovary syndrome Stein-Leventhal syndrome
Primary outcomes
1
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Description
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LDL-Cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
2
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Description
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hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Elisa kit
4
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
5
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Timepoint
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Method of measurement
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7
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Control group: Standard diet designed based on calorie-restricted (500 kcal), 3 serving vegetables, 3 serving fruits, rich in protein, daily for 8 weeks
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Category
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Other
2
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Description
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Intervention group: DASH diet designed based on calorie-restricted (500 kcal), 5 serving vegetables, 5 serving fruits, rich in fiber and whole grains, daily for 8 weeks
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Category
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Other
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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Kashan 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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available