Protocol summary
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Study aim
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Determination of the effect or bread containing Flaxseed on patients with metabolic syndrome
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Design
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48 metabolic syndrome patients are randomly divided in two equal groups clinical trial parallel two blind
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Triglyceride، HDL، FBS ، blood pressure ، waist circumference
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-08-18, 1397/05/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-07-16, 1397/04/25
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Expected recruitment end date
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2018-08-08, 1397/05/17
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effect of bread containing flaxseed on patients with metabolic syndrome
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Public title
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Study of the effect of bread containing flaxseed on patients with metabolic syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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researchers and patients are unaware of the type of bread they are being divided
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-18, 1396/11/29
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Ethics committee reference number
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IR.IAU.SRB.REC.1396.100
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum level of triglyceride
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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By enzyme- mg/dl
2
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Description
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Serum level of HDL
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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By enzyme- mg/dl
3
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Description
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Serum level of FBS
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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By enzyme- mg/dl
4
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Description
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Blood pressure
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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Digital Manometer mmHg
5
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Description
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Waist
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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Strip Meter- Centimeters
6
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Description
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Body mass index
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Timepoint
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At the beginning of the study and the end of the sixth week
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Method of measurement
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Formula weight/ High2
7
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Description
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Physical activity
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Timepoint
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Initially,the middle and end of the sixth week study
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Method of measurement
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Met questionnaire
8
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Description
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Food intake
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Timepoint
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Initially,the middle and end of the sixth week study
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Method of measurement
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Food frequency questionnaire 3 days
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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Control group: intake 2 unit of simple bread containing 100 gram of wheat flour for 6 weeks and twice a day
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Category
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Placebo
1
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Sponsor
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Grant name
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It is not done at the university and it is not a credit for the university
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashani Hospital
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Proportion provided by this source
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1
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available