Effect of two types of high protein diet on component of metabolic syndrome, insulin resistance and inflammatory markers in women with polycystice overy syndrome
The objective of this study is to investigate the effects of two types of high protein diet on lipid profile and inflammatory markers in polycystic ovary syndrome (PCOS) patients.
This randomized crossover, controlled clinical trial includes 30 patients with PCOS. Exclusion criteria were considered any change in lifestyle during interventions and new case of PCOS that using drug for treatment. Participants were randomly assigned to consume a control diet (containing 30% fat, 30% protein and 40% carbohydrate) with animal protein; in intervention diet animal protein (7ser/wk) in the diet (containing 30% fat, 30% protein and 40% carbohydrate) was replaced by plant protein, each for 8 weeks. Total cholesterol (TC), triglyceride concentration (TG), LDL-C, HDL-C, interleukin 6 and c reactive protein (CRP) was calculated as cardiovascular risk factors parameters, at baseline and 8 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307211640N11
Registration date:2013-08-03, 1392/05/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for endocrine sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of two types of high protein diet on component of metabolic syndrome, insulin resistance and inflammatory markers in women with polycystice overy syndrome
Public title
Effect of diet therapy in polycystic overy syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inculsion criteria: using conraceptive pill and metformin during last 3 months; no change in weight during last 3 months; not having specific diet; body mass index between 25-30 kg/m2 and having polysystic overy syndrome (pocs).
Exculsion criteria: change in lifestyle and new case of pcos that using drug for treatmen.
Age
From 18 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences
Street address
No 24, A'rabi Av, Yeman st, Velenjak
City
Tehran
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
929/409
Health conditions studied
1
Description of health condition studied
Polycystice overy syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystice overy syndrome
Primary outcomes
1
Description
lipid profile
Timepoint
2 month after intervention
Method of measurement
kit
2
Description
inflammatory markers
Timepoint
2 month after intervention
Method of measurement
kit
Secondary outcomes
1
Description
weight
Timepoint
2 month after intervention
Method of measurement
scale
Intervention groups
1
Description
in intervention diet animal protein (7ser/wk) in the diet (containing 30% fat, 30% protein and 40% carbohydrate) was replaced by plant protein
Category
Lifestyle
2
Description
control diet (containing 30% fat, 30% protein and 40% carbohydrate) with animal protein
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Endocrine Sciences
Full name of responsible person
Street address
No 24, A'rabi Av, Yeman st, Velenjak
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for endocrine siences
Full name of responsible person
Davod Khalili
Street address
No 24, A'rabi St, Yeman St, Velenjake
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for endocrine siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Parvain Mirmiran
Position
Ph.D
Other areas of specialty/work
Street address
24 No, A'rabi Av, Yeman St, Velenjake
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Parvin Mirmiran
Position
Ph.D
Other areas of specialty/work
Street address
24 No, A'rabi Av, Yeman ST, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institue for Endocrine Sciences
Full name of responsible person
Parvin Mirmiran
Position
Ph.D
Other areas of specialty/work
Street address
No. 24, A'rabi Av, Yeman St, Velenjak
City
Tehran
Postal code
19395-4763
Phone
+98 21 2243 2500
Fax
+98 22402463
Email
mirmiran@endocrine.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)