Comparison of the effect of three high animal protein diet , high plant protein and common protein on indicators related to ovarian aging (premature menopause) in people at risk of premature ovarian failure: a clinical trial
Comparison of the effect of three diets of animal protein, plant protein and common protein on the indicators associated with ovarian aging (premature menopause) in people at risk of premature ovarian failure: a clinical trial
Design
Clinical trial with control group, 2 intervention groups, no blinding, blocked randomized with STATA software .
Settings and conduct
The disease will be treated first, then all three groups will be subjected to special diets for each group. At the beginning and end of the study, the necessary exams will be held there. The study site in Khorramabad city is one of the women's specialist offices
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Women aged 20-40 years in whom menstruation has stopped or two to three periods per year occur in them and the level of antimullerian hormone in them is according to the table in the scientific definitions and the level of FSH in them is above IU / L 10 are at risk for premature menopause.
2. Normal creatine level (1-1.2 mg / dl) or GFR above 70 ml / min
3. No change in supplements (vitamins C and E)
4. Conscious consent to participate in the study
Exclusion criteria
1. Having a history of ovarian surgery
2- Having a history of radiotherapy
Intervention groups
The present patients are divided into 3 groups based on body mass index: normal, overweight and obese, and then are randomly assigned to each of these intervention groups. The randomization method is described in the statistical section. These patients generally get 25% of their diet from protein. Group 1: Diet includes 15% animal protein and 10% plant protein. The second group is on a diet of 15% plant protein and 10% animal protein and the third group is on a normal diet (15% mixture of plant protein and animal protein) for 6 months.
Main outcome variables
Anti Mullerian Hormone(AMH)
Estrogen
Inhibin A
Inhibin B
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201124049481N1
Registration date:2021-08-12, 1400/05/21
Registration timing:prospective
Last update:2021-08-12, 1400/05/21
Update count:0
Registration date
2021-08-12, 1400/05/21
Registrant information
Name
marjan bedakhanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3380 3531
Email address
marjanbadakhanian@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of three high animal protein diet , high plant protein and common protein on indicators related to ovarian aging (premature menopause) in people at risk of premature ovarian failure: a clinical trial
Public title
Comparison of the effect of high protein diet in people at risk of premature menopause
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in their 20s and 40s who have stopped menstruating or two to three periods a year and have Anti Mullerian hormone level as defined in the scientific definitions and FSH level above 10 IU / L. are at risk for premature menopause
Normal creatine or GFR levels above 70
No change in supplements (antioxidants)
Informed consent to participate in the study
Exclusion criteria:
Having a history of radiotherapy
Having a history of ovarian surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in a stratified manner using random permutation blocks. For this purpose, first individuals are classified based on body mass index and then for each category using random block method of individuals in two groups of intervention and a control Will be appointed. The randomization unit is individual. Statistical software is used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institute of Nutrition and Food Industry
Street address
No. 7, Shahid Hafezi St. (West Purple), Shahid Farahzadi Blvd.
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1400.019
Health conditions studied
1
Description of health condition studied
Premature menopause
ICD-10 code
E28.31
ICD-10 code description
Premature menopause
Primary outcomes
1
Description
Serum level of Anti Mullerian Hormone
Timepoint
It will be measured at the beginning and end of the study
Method of measurement
It will be measured by ELISA method
Secondary outcomes
1
Description
Premature menopause
Timepoint
Not applicable
Method of measurement
Based on the AMH level according to the table mentioned in the
2
Description
Serum level of Estrogen
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
3
Description
Serum level of Progestron
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
4
Description
Serum level of Follicle-stimulating hormone (FSH)
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
5
Description
Serum level of Luteinizing Hormone (LH)
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
6
Description
Serum level of Inhibin A
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
7
Description
Serum level of Inhibin B
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
8
Description
Serum level of C-Reactive Protein
Timepoint
At the beginning and 6 months after starting the diet
Method of measurement
It will be measured by ELISA method.
9
Description
Sonography
Timepoint
At the beginning and end of the study in terms of ovarian volume, number of antral follicles, antral thickness
Method of measurement
Ultrasound device
Intervention groups
1
Description
Group 1: Animal high protein diet
Category
Lifestyle
2
Description
Intervention group: Intervention group: high protein plant diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of obstetricians and gynecologists
Full name of responsible person
Marjan bedakhanian
Street address
----------
City
Khoram abad
Province
Lorestan
Postal code
---------------
Phone
+98 21 2237 6471
Fax
+98 21 2209 7419
Email
marjanbadakhanian@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr parvin mirmiran
Street address
No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2209 7419
Email
nnftric@gmail.com
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
25
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjan bedakhanian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
0000000
Email
marjanbadakhanian@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjan bedakhanian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
00000000
Email
marjanbadakhanian@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjan bedakhanian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi St., Shahid Farahzadi Blvd., Ghods Town (West), Tehran, Iran Institute of Nutrition and Food Industry Research
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
000000000
Email
marjanbadakhanian@ymail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
========
When the data will become available and for how long
Up to two months after the end of the intervention
To whom data/document is available
Professors and students in the field of nutrition
Under which criteria data/document could be used
or more extensive research on this disease
From where data/document is obtainable
To Shahid Beheshti School of Nutrition, Dr. Mirmiran
What processes are involved for a request to access data/document