Protocol summary
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Study aim
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The aim of this study is to determine the effects of Dietary Approaches to Stop Hypertension diet on hormonal profiles in patients with polycystic ovary syndrome.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 60 patients with PCOS of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Pregnant during the intervention, hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes or impaired glucose tolerance.
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Intervention groups
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Intervention: Patients will be assigned to receive either low-calorie DASH (intervention group: n=30) or normal diet (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 3 months.
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Main outcome variables
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Outcomes: Anti-Mullerian Hormone (AMH) (primary outcome) and markers of insulin metabolism, hormonal profiles, nitric oxide and malondialdehyde (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201601055623N66
Registration date:
2016-01-11, 1394/10/21
Registration timing:
retrospective
Last update:
2019-11-06, 1398/08/15
Update count:
1
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Registration date
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2016-01-11, 1394/10/21
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2015-12-23, 1394/10/02
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Expected recruitment end date
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2016-01-04, 1394/10/14
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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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The effects of Dietary Approaches to Stop Hypertension (DASH) diet on hormonal profiles in patients with polycystic ovary syndrome
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Public title
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Effect of diet therapy in treatment of women with 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:
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant during the intervention
Hyperplasia
Androgen secreting tumors
Hyperprolactinemia
Thyroid dysfunction
Diabetes or impaired glucose tolerance
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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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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification on pre-intervention BMI (25-29.9 and ≥30 kg/m2) and age (<40 and ≥40 y), subjects will be randomly divided into two groups to receive either low-calorie DASH (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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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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2015-12-22, 1394/10/01
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Ethics committee reference number
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IR.Kaums.REC.1394.130
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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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Anti-Mullerian Hormone
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
Secondary outcomes
1
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Description
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Follicular-stimulating hormone
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Testosterone
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
3
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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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 12 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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Fasting blood sugar
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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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 12 weeks of intervention
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Method of measurement
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Elisa kit
8
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Description
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LH
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
9
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Description
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SHBG
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
Intervention groups
1
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Description
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Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 12 weeks.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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