The assessment of effects of flaxseed on insulin resistance serum, components of metabolic syndrome (lipids profiles, waist circumference and fasting glucose) and serum levels of cytokines secreted from adipose tissue in patients with ulcerative colitis
Determining and comparing the effect of flax consumption on the parameters of metabolic syndrome
Determining and comparing the effects of flax consumption on fasting serum insulin concentration and insulin resistance index (HOMA-IR)
Determining and comparing the effects of flax consumption on serum concentrations of adipokines
- Determining and comparing the effects of flax consumption on serum concentrations of cytokines
Design
A clinical trial is a controlled clinical trial and open-label. Target population: 64 patients with ulcerative colitis who are divided into 32 groups
Settings and conduct
In this study, patients with ulcerative colitis will refer to the gastrointestinal clinic. Among them, the subjects will be followed for 3 months. They receive themselves, they are divided. Blood samples , nutritional and demographic assessmentsare taken from patients at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
-Ulcerative colitis that is histopathologically confirmed.
-The duration of ulcerative colitis should be at least 3 months.
- Patients should be in the active stage of the disease.
exclusion criteria:
-Suffering from other intestinal diseases and disorders, autoimmune diseases, cancer, inflammatory
- Diabetes or hyperlipidemia or drugs that affect the lipid profile
- Consumption of anti-TNF alpha - immunomodulatory modulators
Intervention groups
Patients with mild to moderate disease are divided into two groups receiving 30 grams of ground flaxseed powder daily and the group of patients who do not receive any supplements and receive only the recommendations and routine medical medications.
The assessment of effects of flaxseed on insulin resistance serum, components of metabolic syndrome (lipids profiles, waist circumference and fasting glucose) and serum levels of cytokines secreted from adipose tissue in patients with ulcerative colitis
Public title
Flaxseed on insulin resistance in ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 55 years
Body Mass Index (BMI) 18.5 and above
Histopathologically confirmed ulcerative colitis
The duration of ulcerative colitis should be at least 3 months.
No change in the type and dose of medication used during the last 3 months
Patients are in the active stage (mild to moderate) of the disease.
Willingness to cooperate in this project
Exclusion criteria:
Other intestinal diseases and disorders, autoimmune diseases, cancer, inflammatory and infectious diseases
Diabetes or hyperlipidemia (taking drugs that stimulate insulin secretion (such as glibenclamide) or drugs that affect lipid profile (such as statins))
History of gastrointestinal surgery
Having other gastrointestinal diseases or gastrointestinal surgery during the study
Pregnancy and lactation
Use of anti-TNF alpha or immunomodulatory drugs (methotrexate and prednisolone) at or during the study
Age
From 18 years old to 55 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to the groups by randomly tapping the cards into 2 groups: 1) daily recipient of 30 grams of flaxseed in fully ground powder 2) group of patients who do not receive any supplements and only use routine medical advice and medications They will receive themselves, they will be divided. In this method, three different categories of cards were selected, each of which had the characteristics of one of the study groups by the two-score method. Participants randomly withdrew one card from each category. And were included in that study group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1397.115
Health conditions studied
1
Description of health condition studied
Men and women aged 55-18 years with ulcerative colitis (mild to moderate)
Measurement of blood pressure using mercury sphygmomanometer - Glucose by enzymatic method and using glucose oxidase, total cholesterol by enzymatic method and Cholesterol estrogen and cholesterol oxidase are measured enzymatically using glycerol phosphate oxidase.
2
Description
Insulin Resistance Index
Timepoint
3month
Method of measurement
The Homeostasis Model Assessment of IR (HOMA-IR) has proved to be a robust tool for the surrogate assessment of IR.MA-IR= (glucose in mmol/L x insulin in mIU/mL)/22.5
3
Description
Serum concentrations of adipokine (resistin and visfatin
Timepoint
3month
Method of measurement
using ELISA method and special kit instructions.
4
Description
Serum concentrations of cytokines (interleukin-1 beta and tumor necrosis factor alpha)
Timepoint
3month
Method of measurement
using ELISA method and special kit instructions.
5
Description
Severity of recurrent colitis
Timepoint
3month
Method of measurement
Severity of recurrent colitis based on Mayo score questionnaire
6
Description
Evaluation of food intake
Timepoint
3month
Method of measurement
Evaluation of food intake using food frequency questionnaire 168 items
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Receiver of 30 grams of flaxseed per day in the form of fully ground powder-whole flaxseed was ground and sealed in 250 g packages with a 30 g portion and given to patients. Mix and eat after breakfast
Category
Lifestyle
2
Description
Intervention group2: Intervention group 2: 7 grams of flaxseed oil per day, which is placed in a special container for patients
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Tehran
Full name of responsible person
parvin mirmiran
Street address
Velenjak St. , Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
n.morshedzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
parvin mirmiran
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
n.morshedzadeh@yahoo.com
Grant name
Shahid Beheshti University of Medical Sciences
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nava Morshedzadeh
Position
Ph. D
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
n.morshedzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nava Morshedzadeh
Position
Ph. D
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
n.morshedzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nava Morshedzadeh
Position
Ph. D
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
N.morshedzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
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
Undecided - It is not yet known if there will be a plan to make this available