Effect of soybean flour enriched bread consumption or usual dietary recommendation on serum levels of inflammatory bio markers, lipid profile, glycemic indices and Anthropometric indices in patients with type 2 diabetes: a randomized controlled trial
Design: cross-over clinical trial. Participants: Type 2 diabetic women. The objective: Evaluation the impact of soybean flour enriched bread consumption on serum levels of inflammatory bio markers, lipid profile, glycemic indices and Anthropometric indices in type 2 diabetic women. Inclusion criteria: Type 2 diabetic women, lack of insulin injection. Exclusion criteria: menopause, use of multivitamin and mineral supplementation. Setting and conduct: After a 2 week run-in period, participants will be randomly assigned to soybean flour enriched bread and recommendation group each for 6 weeks. After the first phase of intervention, a 4-week washout period will be applied. Then the participants will be crossed over to the alternate group for additional 6 weeks. To assess the compliance of the participants, we will assess dietary intakes of subjects by the use of dietary records once in every two weeks. Physical activity levels will also be assessed by a physical activity record once in every two weeks. biochemical assessments of inflammatory bio markers including high sensitivity C-Reactive Protein (hs-CRP), serum inter-cellular adhesion molecule (sICAM-1), serum vascular cell adhesion molecule (sVCAM-1), high sensitive interleukin 6 (hs IL-6) and high sensitive tumor necrosis factor-alpha (hs TNF-α) will be measured at the beginning and end of each phases. Appropriate statistical methods will be applied for data analyses. usual dietary recommendation includes healthy food choices. participants in the intervention group will be asked to replace 120 gr of soy bread with the equal amount of their usual bread intake.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061613684N1
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Asma Salarimoghaddam
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2752
Email address
salarimoghaddam@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-07, 1391/09/17
Expected recruitment end date
2013-02-05, 1391/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of soybean flour enriched bread consumption or usual dietary recommendation on serum levels of inflammatory bio markers, lipid profile, glycemic indices and Anthropometric indices in patients with type 2 diabetes: a randomized controlled trial
Public title
Effect of soybean flour enriched bread consumption on inflammation, lipid profile, glycemic indices and Anthropometric indices
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic non menopause; non-pregnant and non-lactating females; aged 30-50 y; body mass index greater than 25; Lack of insulin injection; non-smokers; lack of allergy to soyabean; lack of having a special diet; lack of sever weight loss in the last 3 months; lack of hormone therapy; not having sever infection in the last 3 months; trauma; surgery; hypo- and hyper-thyroidism; vitamin and mineral supplements; and corticosteroids. Exclusion criteria: affecting by the above-mentioned diseases or starting the use of above-mentioned medications; alterations in dosage and type of current medications; getting pregnant; allergy to soyabean; the use of medications and supplements such as multivitamin mineral supplementation; omega-3 fatty acids; smoking
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
This study has a Cross-over design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Approval date
2012-12-02, 1391/09/12
Ethics committee reference number
391431
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
diabetes mellitus, adult-onset, nonketotic, stable, type II
Primary outcomes
1
Description
serum high sensitive-C Reactive Protein (hs-CRP) levels
soybean flour enriched bread group: soy bread will be enriched by substituting 30% of the wheat flour by soybean flour. participants in the intervention group will be asked to replace 120 gr of soy bread with the equal amount of their usual bread intake.
Category
Treatment - Other
2
Description
Recommendation group: information about healthy diet has been prescribed for this group. usual dietary recommendation includes healthy food choices. participants in recommendation group will be asked not to consume foods includes soya during this period of study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jomhoori Square, Khorram Street, Endocrine and Metabolism Research Center, Isfahan, Iran
Full name of responsible person
Gholamreza Askari
Street address
Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
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
Isfahan University Of Medical Sciences
Full name of responsible person
Asma Salarimoghaddam
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2752
Fax
Email
salarimoghaddam@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Asma Salarimoghaddam
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2752
Fax
Email
salarimoghaddam@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Asma Salarimoghaddam
Position
MSc Student Of Nutrition
Other areas of specialty/work
Street address
Department Of Clinical Nutrition, School Of Nutrition and Food Sciences, Isfahan University Of Medical Sciences, Hezar Jerib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2752
Fax
Email
salarimoghaddam@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)