Protocol summary

Study aim
The aim of the present study is to investigate the effects of oral intake of thylakoid with low calorie diet on the metabolic, hormonal and inflammatory factors in obese women with polycystic ovary syndrome.
Design
Randomized double-blind clinical trial with two arm parallel groups
Settings and conduct
The study will be conducted in the Tabriz University of Medical Sciences associated clinics, and supplementation duration will be 12 weeks.The thylakoid and placebo sachets will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of the supplement each group receives.
Participants/Inclusion and exclusion criteria
48 women with polycystic ovary syndrome with BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic diseases are among the exclusion criteria of the study.
Intervention groups
The Individuals in both groups will receive a low-calorie diet considering their dietary habits. Patients in the thylakoid group will take a 5 gram thylakoid sachet with their lunch, daily. In the placebo group, the sachet will contain 5 grams of raw corn starch.
Main outcome variables
Anthropometric indices, body composition, insulin resistance index (HOMA-IR), components of metabolic syndrome, serum levels of free fatty acid, omentin, chemerin, hs-CRP, Neoptrin, FSH, LH, testosterone, SHBG and free androgen index(FAI).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140907019082N9
Registration date: 2018-09-23, 1397/07/01
Registration timing: registered_while_recruiting

Last update: 2018-09-23, 1397/07/01
Update count: 0
Registration date
2018-09-23, 1397/07/01
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-29, 1397/06/07
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oral thylakoid intake on the metabolic, hormonal and inflammatory parameters in obese women with polycystic ovary syndrome under hypocaloric diet: A randomized double-blinded placebo controlled trial
Public title
Effect of oral thylakoid intake with low-calorie diet in the treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients in our selected population were diagnosed with polycystic ovary syndrome according to Rotterdam diagnostic criteria with the diagnosis of the gynecologist.Having at least two of the three following symptoms:1-Abnormal menstrual cycles (oligomenorrhea, amenorrhea)2- Polycystic ovary in ultrasound3- Clinical signs of hyperandrogenism (Acne- Hirsutism) or biochemical symptoms of hyperandrogenism. Women aged 20-40 years Body Mass Index (BMI) range: 30-40 Kg/m2 Moderate activity level Only OCP consumer (estrogen and progesterone combination pills). All participants will only receive OCP. Willingness to participate in the study
Exclusion criteria:
Pregnancy(tendency to become pregnant) or lactation Having any illness that affecting the studied variables (such as liver disease, thyroid disease, cardiovascular disease, renal disease, gastrointestinal disease , Cushing's syndrome,adrenal hyperplasia, androgen-secreting tumors , hyperprolactinemia). Insulin infusion and intakes of blood pressure regulating drugs, statins and or drugs that affect insulin resistance (such as metformin), thiazolidinedione, anti androgens. Using of any vitamin and mineral supplements and or antioxidants or being under certain diets at least two months before the study. Any changes in the therapeutic protocol during the study
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 48 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either thylakoid or placebo group, stratified by age and body mass index (BMI).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (thylakoid or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (prebiotic and placebo), and keep the codes for himself until the end of the study and data analyses.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golghast St.
City
Tabriz
Province
East Azarbaijan
Postal code
516614711
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.447

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Anthropometric indices
Timepoint
Baseline, middle of the study(sixth week) and 12 weeks after intervention
Method of measurement
Seca Scale, stadiometer and strip meter

2

Description
Body composition
Timepoint
Baseline, middle of the study(sixth week) and 12 weeks after intervention
Method of measurement
With the body composition analyzer

3

Description
Lipid profile
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Laboratory evaluation

4

Description
Fasting Blood Glucose (FBG)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Laboratory evaluation

5

Description
Serum level of Insulin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

6

Description
Insulin resistance index
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Using formula

7

Description
Serum levels of free fatty acid (FFA)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

8

Description
Systolic and diastolic blood pressure
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
manometer

9

Description
Serum level of chemerin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

10

Description
Serum level of Omentin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

11

Description
Inflammatory factors
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

12

Description
Serum levels of testosterone
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

13

Description
Serum levels of sex hormone binding glubolin (SHBG)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

14

Description
Serum levels of LH
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

15

Description
Serum levels of FSH
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

16

Description
Serum levels of DHEA-s
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will receive low-calorie diet with a thylakoid supplement for 12 weeks. Thylakoid supplement is a sachet containing 5 grams of thylakoid (extracted from spinach leaves and made by a researcher) which will be dissolved in a glass of water and used once a day with lunch.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group will receive low-calorie diet and placebo for 12 weeks. Placebo is a sachet containing 5 grams of raw corn starch, which will be dissolved in a glass of water and used once a day with lunch.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital affiliated to Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Vaezi
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
alzahrahosp@tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Tabriz University of Medical Sciences,
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research & Technology Dept,Third Floor,Tabriz University of Medical Sciences Central building No. 2, Gulgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Tabriz University of Medical Sciences,
Proportion provided by this source
100
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Pourteymour Fard Tabrizi
Position
Ph.D. candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Fax
+98 41 3334 0634
Email
Fateme.Pourteymour@gmail.com
Web page address
https://nutr.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Associate Professor of Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Fax
+98 41 3334 0634
Email
Abbasalizad_m@yahoo.com
Web page address
https://nutr-en.tbzmed.ac.ir/?PageID=2&ID=39&BasesID=168

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Pourteymour Fard Tabrizi
Position
Ph.D. Candidate in Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Fax
+98 41 3334 0634
Email
Fateme.pourteymour@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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