This study is designed to assess the effect of flaxseed on insulin resistance and oxidative stress in prediabetic patients.In this randomized controlled clinical trial prediabetic patients(n=90), recruited from Shiraz University of Medical Science clinics.They enter in study by inclusion criteria: prediabetic men or women aged 30 to 65 years, a fasting blood sugar of 100 -125mg/ dL or a two-hour blood sugar between 140 to 199 mg/ dL ,body mass index of 25 - 34.9 . Patients who are diagnosed with diabetes or receiving flaxseed or omega-3 supplements within the last three months will be excluded.
They are assigned randomly to three groups : flaxseed (40 gr) and flaxseed(20 gr) as intervention groups and third group as control group. Participants on intervention groups instructed to consume 20 and 40 gr flaxseed for 3 months, in exchange of same amount of charbohydrate and fat in daily diet and control group receive no intervention.Anthropometric,dietary evaluation,laboratory tests including, glycemic profle and insulin resistance ,serum malondialdehyde and serum total antioxidant capacity tests are performed both before and after intervention in three group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051313308N1
Registration date:2013-06-17, 1392/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Afrooz Javidi
Name of organization / entity
Shahid Sadoughi University of Medical Science,International branch
Country
Iran (Islamic Republic of)
Phone
+98 35 1836 7668
Email address
afrooz.javidi@gmail.com
Recruitment status
Recruitment complete
Funding source
a budget that related to the to the thesis of masters degree and Vice chancellor for research,Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-07-22, 1392/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed on insulin resistance and oxidative stress in prediabetic patients
Public title
Flaxseed and prediabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:willing to follow study protocol, scheduling, and testing location
;men and women 30 to 65 years; Body mass index (BMI) of 25 - 34.9 Kg / m2
;prediabetic patients with fasting blood sugar of 100 -125mg/ dl or a two-hour blood sugar between 140 to 199 mg/ dl;not using Insulin ang other glucose lowering medicatins;non smoking status; not using herbal , antioxidant supplementation and omega-3 until 3 months before intervention;without any history of gastrointestinal and kindney disorder;without any acute thyroid, kidney, liver, CVD diseases
Exclusion criteria:unwillingness to follow study protocol, scheduling, and testing location;diagnosis of type 2 diabetes;smoking at least 2 tmes a week;regular history of flaxseed or flaxseed oil supplement or any omega-3 supplement intake
;taking glucose lowering drugs or insulin or estrogen or progesterone drugs
;pregnancy and lactation
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Sadoughi University of Medical Science
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Postal code
8944157963
Approval date
2013-05-19, 1392/02/29
Ethics committee reference number
34132
Health conditions studied
1
Description of health condition studied
prediabetes
ICD-10 code
R73.0
ICD-10 code description
Impaired glucose tolerance prediabetes
Primary outcomes
1
Description
serum concentration of MDA
Timepoint
before and 3 months after intervention
Method of measurement
with spectrophotometer
2
Description
serum total antioxidant capacity
Timepoint
before and 3 months after intervention
Method of measurement
cation decolorization assey ABTS
3
Description
Insulin resistance
Timepoint
before and 3 months after intervention
Method of measurement
HOMA-IR index
4
Description
beta-cell function
Timepoint
before and 3 months after intervention
Method of measurement
ELISA kit
5
Description
Insulin sensitivity
Timepoint
before and 3 months after intervention
Method of measurement
QUICKI index
Secondary outcomes
1
Description
weight
Timepoint
before and after intervention
Method of measurement
scale with accuracy 100 gr
2
Description
Height
Timepoint
before and after intervention
Method of measurement
tape meter instaled on the wall
3
Description
BMI(Body Mass Index)
Timepoint
before and after intervention
Method of measurement
Calculation:Weight (kg) / squared height (m)
4
Description
Total energy intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
5
Description
charbohydate intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
6
Description
protein intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
7
Description
fat intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
8
Description
fiber intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
9
Description
saturated fatty acid intake
Timepoint
before and after intervention
Method of measurement
24 hour recall
10
Description
mono unsaturated fatty acid intake(MUFA)
Timepoint
before and after intervention
Method of measurement
24 hour recall
11
Description
poly unsaturated fatty acid intake(PUFA)
Timepoint
before and after intervention
Method of measurement
24 hour recall
Intervention groups
1
Description
In first intrvention group,prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 20 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level.
Category
Treatment - Other
2
Description
In second intrvention group, prediabetic individuals,aged 30-65 years, will recieve a daily allotment of 40 gr ground flaxseed for 12 week.they will be instructed to incorporate the suplement in their daily meals using method described in instruction pamphlet.They are instructed to substitute flaxseed for some of their usual carbohydrate and fat consumed at the meal.The subjects are told not to change diet and activity level
Category
Treatment - Other
3
Description
In control group,prediabetic individuals,aged 30-65 years, will recieve no intervention.The subjects are told not to change diet and activity level.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Science
Full name of responsible person
Dr.Mohammad Hasan Eftekhari
Street address
School of Health and Nutrition, Fatholmobin alley, Kooye Zahra street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science,International branch
Full name of responsible person
Dr. Mohammad Hasan Sheikhha
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science,International branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science-Intrnational branch
Full name of responsible person
Afrooz Javidi
Position
Msc student of health science in nutrition
Other areas of specialty/work
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Postal code
8944157963
Phone
+98 35 1836 7668
Fax
+98 35 1836 7636
Email
afrooz.javidi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Hasan Mozaffari Khosravi
Position
PHD of Nutrition,professor
Other areas of specialty/work
Street address
Health School, Daneshjoo Blvd,Yazd
City
Yazd
Postal code
89156-887
Phone
+98 35 1624 5900
Fax
+98 35 1623 8555
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Saduoghi University of Medical Science,International branch
Full name of responsible person
Afrooz Javidi
Position
MSc student
Other areas of specialty/work
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Postal code
8944157963
Phone
+98 35 1836 7668
Fax
+98 35 1836 7636
Email
afrooz.javidi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)