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The Effect of Inulin-type Fructans, with different degrees of polymerization, on metabolic parameters, hormonal status, inflammatory markers, oxidative stress, and endothelial dysfunction, in women with Polycystic Ovary Syndrome: A Randomized, Double-blind, Controlled, Clinical Trial

Protocol summary

Study aim
Evaluation of the Effect of Inulin-type Fructans, with different degrees of polymerization, on metabolic parameters, hormonal status, inflammatory markers, oxidative stress, and endothelial dysfunction, in women with Polycystic Ovary Syndrome
Design
A randomized, double blind, parallel, placebo-controlled clinical trial, on 75 women with Polycystic Ovary Syndrome. Randomization will be done by Permuted Block Randomization.
Settings and conduct
The present clinical trial will be conducted on 75 patients with Polycystic Ovary Syndrome. The diagnosis will be done by an expert gynecologist, based on Rotterdam criteria. The study duration will be 12 weeks. the Patients will be included in one of the three groups, including HPI, Oligofructose-enriched Inulin and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria, including patients with Polycystic Ovary Syndrome, between 18 to 40 years old, BMI between 25 to 35, willingness to cooperate, not intended to become pregnant. Exclusion criteria, including pregnancy and lactation, smoking or alcohol use, being on specific diets or training plans, involved with other endocrine disorders or gastrointestinal disorders, current or previous (last 3 months) use of special drugs or supplements.
Intervention groups
Patients will be included in one of the following groups: 1)High Performance Inulin 2)Oligofructose-enriched Inulin 3)Maltodextrin as placebo
Main outcome variables
Anthropometric indices; dietary intakes; blood pressure; hirsutism severity score; quality of life score; mood disorders score; physical activity level; serum hs-CRP; serum Nitric Oxide; serum Endothelin-1; serum total Testosterone; serum lipid levels; fasting plasma glucose; fasting Insulin; serum SHBG; Free Androgen Index (FAI); Insulin resistance indices ( QUICKI and HOMA-IR).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101101005062N11
Registration date: 2020-11-10, 1399/08/20
Registration timing: registered_while_recruiting

Last update: 2020-11-10, 1399/08/20
Update count: 0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Inulin-type Fructans, with different degrees of polymerization, on metabolic parameters, hormonal status, inflammatory markers, oxidative stress, and endothelial dysfunction, in women with Polycystic Ovary Syndrome: A Randomized, Double-blind, Controlled, Clinical Trial
Public title
The effect of Inulin-type Fructans, in treatment of Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 to 40 years old BMI between 25 to 35 Kg/m2 Unwillingness to cooperate with the project Not intended to become pregnant
Exclusion criteria:
Current consumption (or during the previous 3 months) of oral contraceptive pills, hormone therapy, anti-diabetic or insulin sensitizing drugs, weight loss drugs, probiotic, synbiotic or prebiotic supplements, antibiotics, proton pomp inhibitors, multivitamin or mineral supplements or other nutritional supplements History of other endocrine disorders, including Thyroid disorders, Hyperprolactinemia, Cushing syndrome, Diabetes or Glucose Intolerance, and Androgenic disorders Pregnancy and lactation Smoking or alcohol consumption History of Gastrointestinal disorders, such as Inflammatory Bowel Diseases and Irritable Bowel Syndrome
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by Permuted Block Randomization, via the website, https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block has capacity for four subjects. After that, subjects will be randomly assigned to treatment or placebo groups, within each block. Random assignment will be done using a random chain, which will be extracted from the site.
Blinding (investigator's opinion)
Double blinded
Blinding description
Two ype of Inulin supplements and palcebo will be given to patients in similar packs. Both patients and the researcher are not aware of being in intervention or placebo group. Inulin supplements and placebo are relatively identical, in terms of color, taste and solubility.
Placebo
Used
Assignment
Parallel
Other design features
The patients will be divided into three groups: High Performance Inulin- Oligofructose-enriched Inulin- Placebo

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezarjerib St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.471

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
The score of hirsutism severity in modified Ferriman-Galway Scale
Timepoint
At the beginning of the study, at the end of the sixth week and at the end of the study.
Method of measurement
modified Ferriman-Galway Scale

2

Description
Free Androgen Index
Timepoint
At the beginning of the study and at the end of the intervention.
Method of measurement
Based on serum total Testosterone and serum SHBG

3

Description
Serum hs-CRP
Timepoint
At the beginning of the study and at the end of the intervention.
Method of measurement
ELISA immunoassay kit

4

Description
Serum Endothelin-1
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
ELISA immunoassay kit

5

Description
Serum Fasting Plasma Glucose
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Calorimetric assay

6

Description
Serum Fasting Insulin
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
ELISA immunoassay kit

7

Description
Insulin resistance
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
(Quantitative Insulin Sensitivity Check Index (QUICKI)

8

Description
Insulin resistance
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Homeostatic Model Assessment Index (HOMA)

9

Description
Serum Triglyceride level
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Calorimetric assay

10

Description
Serum Low-Density Lipoprotein (LDL-cholesterol)
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Calorimetric assay

11

Description
Serum High-Density Lipoprotein (HDL-cholesterol)
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Calorimetric assay

12

Description
Serum Total Cholesterol
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
Calorimetric assay

13

Description
Dietary intakes
Timepoint
At the beginning of the study, at the end of the sixth week, and at the end of the intervention.
Method of measurement
Three-days Food Record

14

Description
Serum Nitric Oxide level
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
ELISA Immunoassay kit

15

Description
Serum Sex-Hormone Binding Globulin (SHBG)
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
ELISA Immunoassay kit

16

Description
Serum Total Testosterone
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
ELISA Immunoassay kit

17

Description
Mood status score
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
DASS-21 Questionnaire

18

Description
Quality of life score
Timepoint
At the beginning of the study, and at the end of the study (end of the twelfth week).
Method of measurement
PCOS quality-of-life questionnaire (PCOSQ)

Secondary outcomes

1

Description
Weight
Timepoint
At the beginning of the study, at the end of the sixth week and at the end of the intervention
Method of measurement
Standard weight scale

2

Description
Systolic and Diastolic blood pressure
Timepoint
At the beginning of the study, at the end of the sixth week and at the end of the intervention
Method of measurement
Digital Sphygmomanometer

3

Description
Body Mass Index
Timepoint
At the beginning of the study, at the end of the sixth week and at the end of the intervention
Method of measurement
It will calculated by weight divided by height (in meters)

Intervention groups

1

Description
Intervention group: High Performance Inulin group. With Degree of Polymerization equal or more than 22, with commercial name Frutafit® TEX, Sensus/Netherlands. The supplement will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals.
Category
Treatment - Other

2

Description
Intervention group: Oligofructose-enriched inulin, with average Degree of Polymerization between 8 to 13, with commercial name Frutafit® IQ, Sensus/Netherlands. The supplement will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals.
Category
Treatment - Other

3

Description
Control group: Maltodextrin powder, 10 grams per day. The placebo will be given to patients in 10 grams packs. It should be consumed by dissolving in water or yogurt, with main meals.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Zahra Shahshahan Private Gynecology office
Full name of responsible person
Rahele Ziaei and Zahra Shahshahan
Street address
Molla-sadra building, Amadegah St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3221 1888
Email
r.ziaei92@gmail.com

2

Recruitment center
Name of recruitment center
Saint Al-zahra Hospital Gynecology and ObstetricsClinic
Full name of responsible person
Rahele Ziaei and Dr. Zahra Shahshahan
Street address
Gynecology and Obstetrics Clinic, Al-zahra Hospital, Soffe St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
‏8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rahele Ziaei
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8487
Email
r.ziaei92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8487
Email
ghiasvand@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rahele Ziaei
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8487
Email
r.ziaei92@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Major parts of data will be available for the population.
When the data will become available and for how long
12 months after publishing the results.
To whom data/document is available
Available for academic researchers, who work in academic and scientific institutions.
Under which criteria data/document could be used
For conducting similar projects.
From where data/document is obtainable
Dr. Reza Ghiasvand ghiasvand@hlth.mui.ac.ir
What processes are involved for a request to access data/document
The data will be send one month after receiving the request.
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