Protocol summary
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Study aim
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Determination of the Effect of Supplementation of flaxseedOil on Glycemic Control in Pre-Diabetes Patients with Overweight
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Design
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In this study, 40 individuals with pre-diabetes who are referred to the Isfahan Cardiovascular Center are eligible to enter the study. Participants are randomly divided into intervention and control groups and assigned to each participant a code.
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Settings and conduct
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This is a double-blind controlled clinical trial of overweight pre-diabetic individuals. At the beginning of the study, general information questionnaire including age, height, weight, occupation, history of disease, type and dosage of consumable drugs will be completed. Then, the subjects will be randomly divided into two groups and consumed flaxseed oil (1 g, 2 times a day) and placebo (1 g, 2 times a day) for 14 weeks. The participants in the study, a researcher and a clinical expert will be not aware on the type of supplementation used in each group. Serum samples from the participants at the beginning and end of the study will be collected by blood sampling and centrifugation. At the end of the study, Fasting Insulin, FBS and HOMA-IR, QUIKI-IR will be used. The completion of the three-day registration of the food intake and the physical activity registration questionnaire will be carried out at the beginning of the study and the end of the seventh and fourteenth weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include those with fasting blood glucose levels between 100 and 125 mg / dL, with a body mass index of 25 to 29.9.
Exclusion criteria:
Getting oral hypoglycemic drugs and insulin injections, getting any acute and chronic disease, any kind of allergy or intolerance to your seed oil, smoking, having severe activity and unusual diet, women having a monthly cycle of at least 6 Last month, use of anti-inflammatory drugs as a base, having regular intake of thy juice, flaxseed oil or fish oil supplements, fish consumption of more than 340 g per week, and soy consumption, once or more than once a week, fixed
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Intervention groups
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The intervention group that receive flaxseed oil for 14 weeks daily(2 capsules of 1000 mg of oil per day), and the control group that received the same oral administration as the intervention group containing paraffin oil for ( 2 capsules of 1000 mg per day ).
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Main outcome variables
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Fbs ؛ insulin
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:
IRCT20120913010826N27
Registration date:
2018-02-07, 1396/11/18
Registration timing:
registered_while_recruiting
Last update:
2018-03-13, 1396/12/22
Update count:
1
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Registration date
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2018-02-07, 1396/11/18
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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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2017-11-06, 1396/08/15
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Expected recruitment end date
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2017-12-06, 1396/09/15
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Actual recruitment start date
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2017-12-07, 1396/09/16
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Actual recruitment end date
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2018-03-06, 1396/12/15
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Trial completion date
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empty
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Scientific title
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The effects of flaxseed oil supplementation in Glycemic control and body composition on overweight pre-diabetes patients
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Public title
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Effect of flaxseed oil on pre-diabetes control
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Fasting blood glucose should be between 100 and 125 mg / dL
The body mass index is between 25 and 29.9.
Exclusion criteria:
Receive oral hypoglycemic drugs and insulin injections
Cure for any type of acute and chronic disease
Any kind of allergy or intolerance to your seed oil
smoking
Having severe activity and unusual diet
Women having a monthly cycle for at least 6 months
Use of anti-inflammatory drugs
Having regular consumption of your seed, flaxseed oil, fish oil, fish and soy supplement
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
40
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals are randomly assigned to one of two study groups with the help of a random number table and received the intervention of the same group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, clinical caregivers and investigators will not be aware of the type of intervention. And the intervention in each group will be marked with codes A and B.
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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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2016-11-30, 1395/09/10
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Ethics committee reference number
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IR.SSU.SPH.REC.1396.20
Health conditions studied
1
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Description of health condition studied
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Prediabet
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ICD-10 code
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R73.02
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ICD-10 code description
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Impaired glucose tolerance (oral)
Primary outcomes
1
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Description
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Fasting insulin
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Timepoint
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Before the intervention and 14 weeks after the intervention
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Method of measurement
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Blood test, µU/ml
Secondary outcomes
1
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Description
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Weight
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Timepoint
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Before the intervention and 14 weeks after the intervention
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Method of measurement
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With scale
2
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Description
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Fbs
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Timepoint
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Before the intervention and the end of the week 14
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Method of measurement
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Blood test، mg/dl
Intervention groups
1
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Description
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Intervention group: To the intervention group, for 2 weeks, 2 capsules of 1000 mg of linseed oil will be given to the Barij Essen Pharmaceutical Company in Kashan. Given the length of the study, 196 capsules are for each person
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Category
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Prevention
2
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Description
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Intervention group: To placebo recipients, during the same periodic study, a placebo will be given to the recipient of the supplementation of flaxseed oil containing oral paraffin from the pharmaceutical company Barij Essen in Kashan. Given the length of the study, 196 capsul.
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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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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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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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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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Academic
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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is 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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Not applicable
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Title and more details about the data/document
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Data report will be shared after publishing the paper.
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When the data will become available and for how long
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Six months after publish
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Using for Meta-analysis
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From where data/document is obtainable
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Center nutrition, public health, univercity of medical sciencies yazd Tel: 009835 31492239 Email: azadehnajarzadeh@gmail.com Azadenadjarzadeh
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What processes are involved for a request to access data/document
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It will be sent two weeks after the receipt of the email with the consent of the co-workers
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Comments
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