Protocol summary
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Study aim
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The effect of concentrated pomegranate juice on depression score , insulin resistance , oxidative and antioxidant markers in women with polycystic ovary syndrome.
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Design
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clinical trial, Randomized, non-blind, having Control group
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Settings and conduct
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First, we select 44 patients with PCOS who referre to Shahid Beheshti Clinic in Isfahan and divide into two groups. Participants were asked to record their 3-day dietary intake (2 days per week and one day off) and to complete the DASS questionnaire and the intervention is implemented.Then, anthropometric measurements and blood pressure are performed and their fasting blood samples are taken and then the intervention is performed.
Individuals are asked not to alter their dietary intake, calorie intake, eating habits, and exercise routine during the study period. After 8 weeks, all of the above steps will be repeated.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 18≤age≤40, BMI ≥ 25, being single, not having acute and chronic diseases such as: cardiovascular disease, diabetes, hypothyroidism, hypertension, dyslipidemia, depression, not following a specific diet and exercise program, non-use of drugs such as oral contraceptive pill, hormonal drugs, anti-diabetic drugs, antioxidant supplements, not consuming pomegranates at least 2 months before the study. Exclusion criteria: pregnancy,not consuming concentrated pomegranate juice completely, not willing to continue participating in the study.
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Intervention groups
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we will give concentrated pomegranate juice 45 cc daily to the intervention group and and we say to dilute it with 180 cc water daily and consume in the evening. The control group received no intervention.
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Main outcome variables
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Depression score; Total antioxidant capacity ; Malondialdehyde ; Triglyceride ; Total cholesterol ; HDL-C ; LDL-C ; Fasting Blood Sugar; Insulin; Insulin resistance; weight; Body-mass index.
General information
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Reason for update
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Correction of sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191109045383N1
Registration date:
2019-11-16, 1398/08/25
Registration timing:
retrospective
Last update:
2020-04-13, 1399/01/25
Update count:
1
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Registration date
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2019-11-16, 1398/08/25
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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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2018-04-14, 1397/01/25
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Expected recruitment end date
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2019-03-03, 1397/12/12
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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 Effect Of Concentrated Pomegranate Juice On Depression score , Insulin Resistance(HOMA-IR) , oxidative And Antioxidant Markers (TAC , MDA) In Women With Polycystic Ovary Syndrome(PCOS)
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Public title
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The effect of pomegranate juice concentrate in 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:
18≤Age≤40
BMI ≥ 25
Being single
Not having acute and chronic diseases such as: cardiovascular disease, kidney, liver, diabetes, hypothyroidism, hyperthyroidism, asthma, neoplastic, hyperprolactinemia, malabsorption disorders, hypertension, dyslipidemia, (new or during 6 months).
No Depression
Not following a specific diet.
Not following a specific exercise program.
Non-use of drugs such as contraceptive pills (Oral contraceptive pill), hormonal drugs, anti-diabetic drugs, anti-obesity drugs, antioxidant supplements and multivitamin minerals, blood lipid lowering drugs.
Not smoking
Not allergic to pomegranate and its products.
Not consuming pomegranates and pomegranate-containing products at least 2 months before starting the study
Exclusion criteria:
Pregnancy
Not consuming Concentrated Pomegranate Juice completely
Not willing to continue participating in the study
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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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No information
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, we select all individuals using available sampling method and after describing the aims and methods of the study, if they wish to participate in the study, we randomly divided them into two groups of Concentrated pomegranate juice and control.
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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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Other
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Other design features
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In this study, all individuals are divided into two groups: the first group receives the intervention and the second group is the control group that receives no intervention.
Ethics committees
1
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Ethics committee
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Approval date
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2018-03-04, 1396/12/13
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Ethics committee reference number
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396806
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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ICD-10 code description
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Primary outcomes
1
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Description
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Evaluation of malondialdehyde in women with polycystic ovary syndrome
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Timepoint
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Baseline and 8 weeks after starting the study
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Method of measurement
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Measurement of serum malondialdehyde by calorimetric method using kiazist kit
Secondary outcomes
1
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Description
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Evaluation of total antioxidant capacity in women with polycystic ovary syndrome
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Timepoint
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Baseline and 8 weeks after starting the study
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Method of measurement
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Measurement of serum total antioxidant capacity by cupric reducing antioxidant capacity (CUPRAC) method using kiazist kit
2
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Description
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Evaluation of insulin resistance in women with polycystic ovary syndrome
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Timepoint
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Baseline and 8 weeks after starting the study
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Method of measurement
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Measurement of Insulin Resistance Using Formula (fasting plasma glucose (mMol/L) × insulin (µIU/mL))/22.5. The levels of serum insulin will be determined using ELISA kit (AccuBind, Monobind Inc., USA) and fasting blood sugar will be measured by enzymatic photometric method using standard kits (Pars Azmun, Tehran, Iran).
3
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Description
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Depression score
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Timepoint
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Baseline and 8 weeks after starting the study
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Method of measurement
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Depression Anxiety Stress Scale-21 (DASS-21) questionnaire
Intervention groups
1
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Description
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Intervention group: 45 ml Concentrated Pomegranate Juice for 8 weeks with 180 cc water, in the afternoon, Takeda factory of East Azarbaijan .
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Category
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Treatment - Other
2
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Description
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Control group: Does not receive any intervention.
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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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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clinical measurements as word file can be shared for other researchers
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When the data will become available and for how long
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the main data are available one year after pulication
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To whom data/document is available
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data are available for all clinicians especially RDNs.
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Under which criteria data/document could be used
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data users had not allowed to analyze this data for drug industries.
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From where data/document is obtainable
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mail to this address: maryamabedinii93@gmail.com
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What processes are involved for a request to access data/document
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just mail to this address and request with IRCT-related code: maryamabedinii93@gmail.com
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Comments
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