Protocol summary
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Study aim
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The aim of this study is to determine the effects of soy intake on metabolic profiles in patients with polycystic ovary syndrome.
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Design
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Study design: Parallel 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 polycystic ovary syndrome of eligible and referred to Akbarabadi Hospital affiliated to Iran University of Medical Sciences, Tehran, 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 and aged 18 to 40 years will be included in this study. Exclusion criteria: Pregnant women Hyperprolactinaemia Thyroid dysfunction Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
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Intervention groups
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Intervention: Patients will be assigned to receive either soy plus low calorie diet (n=30) or control plus low calorie diet (n=30).
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Main outcome variables
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Insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (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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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201701295623N104
Registration date:
2017-02-01, 1395/11/13
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-02-01, 1395/11/13
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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, Iran University of Medical Sciences
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Expected recruitment start date
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2017-01-17, 1395/10/28
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Expected recruitment end date
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2017-01-24, 1395/11/05
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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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Clinical trial of the effect of soy intake compared with the control diet on metabolic profiles in patients with polycystic ovary syndrome
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Public title
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Effect of diet therapy in treatment of patients 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:
Aged18–40 years old
Patients with PCOS according to Rotterdam criteria
Exclusion criteria:
Pregnant women
Hyperprolactinaemia
Thyroid dysfunction
Endocrine diseases including diabetes, impaired glucose tolerance and gastrointestinal problems
Took medications, such as hormonal contraceptives, insulin sensitising agents, anti-inflammatory or antidiabetic and lipid lowering drugs, or any other medications that might affect reproductive physiology during the 8-week intervention.
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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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No information
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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 for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either soy supplements (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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Not blinded
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Blinding description
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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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2017-01-16, 1395/10/27
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Ethics committee reference number
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IR.IUMS.REC.1395.26552
Health conditions studied
1
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Description of health condition studied
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Polycystic ovarian 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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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
2
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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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Using HOMA formula
3
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Description
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Insulin sensitivity
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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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Using QUICKI formula
Secondary outcomes
1
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Description
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Hs-CRP
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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
2
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Description
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HDL
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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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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
4
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Description
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Total 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
5
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Description
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Total antioxidant
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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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Malondialdehyde
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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
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
8
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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 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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Intervention group: Soy-protein diet, 0.8 g/kg protein (35% animal protein, 35% soy protein, and 30% other vegetable proteins), daily for 8 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, 0.8 g/kg protein (70% animal and 30% vegetable proteins), daily for 8 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, Iran 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