Evaluation of the effects of Oligpin supplementation on inflammatory and metabolic profile in patients with polycystic ovary syndrome.
Design
Double blind randomized controlled trial
Settings and conduct
Eighty patients with PCOS (according to Androgen Excess Society criteria) without thyroid disease and androgenic hormone secretory tumors, at the age range of 18-40 years old will be randomly assigned to the groups receiving either oligopin or placebo (once a day) for 12 weeks. This randomized, double-blind trial will be conducted at Shariati hospital affiliated to Tehran University of Medical Sciences in the Iran. FSH, LH, SHBG, fasting blood sugar, insulin, HDL, LDL-C, total cholesterol, triglycerides ,blood pressure, body composition, weight, height and waist circumferences will be measured before and 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: PCOS diagnosis (according to Androgen
Excess Society criteria); hyperandrogenism /
hyperandrogenemia (testosterone >70ng/dl) and/or
oligomenorrhea (<8 spontaneous menses per year)
and/or polycystic ovarian morphology.
Women aged from 18 to 40; Normal prolactin; thyroid function; 17-OH progesterone; No evidence of Androgenic hormone secretory tumors;No Cushing's syndrome or acromegaly
Exclusion criteria:Use of either oral contraceptives, steroids hormones or other medications that could modify the metabolism 1 months before the trial.
Intervention groups
Intervention group: oral intake of oligopine capsule (50 mg once daily) for 12 weeks. Control group: oral intake of placebo (once daily) for 12 weeks.
The effects of oligopin supplementation on inflammatory and metabolic parameters in women with polycystic ovary syndrome.
Public title
The effect of oligopin on PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCOS diagnosis according to Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound
Women aged from 18 to 40 years old
Normal prolactin
normal thyroid function
17-OH progesterone
No evidence of Androgenic hormone secretory tumors
No Cushing's syndrome or acromegaly
Exclusion criteria:
Using either oral contraceptives or steroids hormones during 1 month before the onset of the trial
Using medications that could modify the metabolism during 1 month before the onset of the trial
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization method
Blinding (investigator's opinion)
Double blinded
Blinding description
The supplement and placebo will be prepared in identical shape, color and smell. Investigators and participants will be blind of the allocation process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Endocrinology Metabolism Research Institute, Tehran University of Medical Scienc
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411413137
Approval date
2017-11-30, 1396/09/09
Ethics committee reference number
IR.TUMS.EMRI.REC.1396.00163
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
S.H.B.G) Sex Hormon Binding Globolin)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
2
Description
FSH
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
3
Description
LH
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
4
Description
fasting blood sugar
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
5
Description
testosterone
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
6
Description
DHEA-S
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
Secondary outcomes
1
Description
HDL-C
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
2
Description
LDL-C
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
3
Description
Total cholesterol
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
4
Description
TG
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
5
Description
Cr
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
6
Description
Hs-CRP
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
7
Description
HbA1C
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
8
Description
Insulin
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
9
Description
prolactin
Timepoint
Before and 12 weeks after the intervention
Method of measurement
ng/mL
10
Description
TSH
Timepoint
Before and 12 weeks after the intervention
Method of measurement
blood test
Intervention groups
1
Description
Intervention group: oral intake of oligopin (50mg capsule) after lunch, once a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: oral intake of placebo after lunch, once a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute
Full name of responsible person
Saeed Hosseini
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0071
Email
saeedhmdphd@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mostafa Qorbani
Street address
Alborz University of Medical Sciences, North Taleqani Blvd, Taleqani Square
City
Karaj
Province
Alborz
Postal code
-
Phone
+98 21 8822 0071
Email
mqorbani1379@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Saeed Hosseini
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0071
Email
saeedhmdphd@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Saeed Hosseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0071
Email
saeedhmdphd@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Saeed Hosseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, 1411413137,Iran
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0071
Email
saeedhmdphd@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Endocrinology & Metabolism Research Institute
Full name of responsible person
Asieh Mansour
Position
PhD. student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0071
Email
asiehmansour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data collected for the primary and secondary outcomes will be shared.
When the data will become available and for how long
access starting 18 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of our study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
To access the required data, the researchers can contact Ms. Asieh Mansour: email address:asiehmansour@yahoo.com
What processes are involved for a request to access data/document
The researcher should provide a brief description of the aims of his study. The request will be assessed by the researchers, and if we agree to the request, the requested data will be emailed.