View older revisions Content changed at 2022-11-03, 1401/08/12

Protocol summary

Study aim
Determination of the effect or bread containing Flaxseed on patients with metabolic syndrome
Design
48 metabolic syndrome patients are randomly divided in two equal groups clinical trial parallel two blind
Settings and conduct
patients with metabolic syndrome from Kashani Hospital were randomly divided into two groups. The rate of lipid profile, , BMI,wight ,waist circumference, blood pressure, FBS, and height were measured. In the intervention group, two units of 20% flaxseed bread and the control group intake 2 simple breads. And after 6 weeks the blood sampling will be done again
Participants/Inclusion and exclusion criteria
Inclusion criteria: study Having 3 Indices of 5 Metabolic Syndrome Indicators: Waist circumference is more than 102 centimeters for men and more than 88 centimeters for women, The level of triglyceride is greater than or equal to 150 mg / dL, HDL cholesterol levels less than 40 for men and less than 50 mg per decilitre for women, The fasting blood sugar level is greater than or equal to 100 mg / dL, The blood pressure is greater than or equal to 130/85 mmHg , Men and women 20-50 years old, Patients who agree to participate in the study. Condition of failure to enter: Tobacco use, Consumption of flax seed bread in the last 6 months ,Pregnancy, breast feeding, menopause Exclusion criteria: The incidence of diseases or the use of drugs that affect metabolic indexes, The incidence of gastrointestinal diseases during the research so that the continuation of the research is not possible, Pregnancy during the project, Chang in types or doses of drugs, Participants do not cooperate in different stages of the study
Intervention groups
1- The intervention group: received 2 unit flax seed bread 20% 2- The control group: receives 2 units of bread containing 100 grams of wheat
Main outcome variables
Triglyceride، HDL، FBS ، blood pressure ، waist circumference

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180305038966N2
Registration date: 2018-08-18, 1397/05/27
Registration timing: retrospective

Last update: 2022-11-03, 1401/08/12
Update count: 1
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Nahid Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 1815
Email address
nutrition@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2018-08-08, 1397/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of bread containing flaxseed on patients with metabolic syndrome
Public title
Study of the effect of bread containing flaxseed on patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 3 Indices of 5 Metabolic Syndrome Indicators. Waist circumference is more than 102 centimeters for men and more than 88 centimeters for women. The level of triglyceride is greater than or equal to 150 mg / dL. HDL cholesterol levels less than 40 for men and less than 50 mg per decilitre for women. The fasting blood sugar level is greater than or equal to 100 mg / dL. The blood pressure is greater than or equal to 130/85 mmHg Men and wemen 20-50 years old Patients who agree to participate in the study
Exclusion criteria:
Tobacco use - Adherence to a particular diet - Consumption bread of flaxseed in the last 6 months - Pregnancy, breast feeding, menopause
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The 48 patients selected are divided into two groups of intervention and placebo. In the present study, a simple randomization method will be used, the randomization unit will be used individually and we will use the random number table method to generate random sequences. A random number table is a massive set of numbers that is generated without a definite pattern and completely randomized. The next step is to hide random assignments and use non-transparent sealed envelopes with random sequences. will be. Then, based on the sample size of the study, a number of envelopes with an aluminum wrapper are prepared and each random sequence created on a card is recorded and the cards are inserted into the envelopes respectively. At the time of the registration of the participants, According to the order of entry of eligible participants of the study, one of the envelopes is opened in sequence and the participant's group is revealed
Blinding (investigator's opinion)
Double blinded
Blinding description
researchers and patients are unaware of the type of bread they are being divided
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Science and Research Tehran
Street address
میدان دانشگاه، بلوار شهدای حصارک
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.IAU.SRB.REC.1396.100

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum level of triglyceride
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme- mg/dl

2

Description
Serum level of HDL
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme- mg/dl

3

Description
Serum level of FBS
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme- mg/dl

4

Description
Blood pressure
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Digital Manometer mmHg

5

Description
Waist
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Strip Meter- Centimeters

6

Description
Body mass index
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Formula weight/ High2

7

Description
Physical activity
Timepoint
Initially,the middle and end of the sixth week study
Method of measurement
Met questionnaire

8

Description
Food intake
Timepoint
Initially,the middle and end of the sixth week study
Method of measurement
Food frequency questionnaire 3 days

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intake 2 unit of bread containing 20 gram of flax seed flour and 80 gram of wheat flour for 6 weeks and twice a day
Category
Treatment - Other

2

Description
Control group: intake 2 unit of simple bread containing 100 gram of wheat flour for 6 weeks and twice a day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashni hospital and patients referred to other hospitals and private clinics in isfahan
Full name of responsible person
Nahid Shakeri
Street address
Kashani Ave, Kashani hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashani Hospital
Full name of responsible person
Nahid Shakeri
Street address
Kashani Ave, Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir
Grant name
It is not done at the university and it is not a credit for the university
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashani Hospital
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Shakeri
Position
Master nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Kashani Ave,Kashani hospital
City
isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
NahidShakeri
Position
University staff
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Kashani Ave,Kashani Haspital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Shakeri
Position
Student master nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Hesarak Blvd, University Square
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 1815
Email
nutrition@mail.mui.ac.ir

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
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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