Assessment of the effect of probiotic supplement and soy milk on lipid profiles, Blood sugar, insulin resistance status and blood pressure in diabetic patients type II
Diabetes mellitus is the most common chronic metabolic diseases in both developing and developed countries. Soy products can have beneficial effects on metabolic disorders. The purpose of this study is to investigate the effect of soy milk and probiotic capsule together on the lipid profile, blood sugar, blood pressure and insulin resistance status in patients with diabetes type II. This study is a controlled randomized, clinical trial with placebo which was performed on 100 patients, aged 40-75 years old, they will be excluded from the study in case of having any acute and chronic disease. Patients were randomly divided into 4 recipient groups: 1- soy milk + probiotic supplement 2- soy milk + placebo 3- milk + placebo 4 - probiotic capsules and will receive a glass of milk (240 ML) and a capsule every day for 6 weeks. Then the weight changes, blood pressure, fasting blood sugar, lipid profile and insulin are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080423495N1
Registration date:2016-01-22, 1394/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Azime Hasan poor
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3762 2725
Email address
h.nutritionist@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of probiotic supplement and soy milk on lipid profiles, Blood sugar, insulin resistance status and blood pressure in diabetic patients type II
Public title
the effect of probiotic supplement and soy milk in diabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : having willingness to cooperate in the plan and presenting the written consent form ; being 75-40 years old ; diagnosis of diabetes based on a specialist opinion ; being residence of Fars province ; having the ability to understand the objectives of the study
Exclusion criteria : any acute and chronic disease that cause patients not to be able to follow research protocols ; consumption of foods and products that contain probiotic bacteria 3 weeks before the start of the intervention and during the intervention ; Change in dose of drug or insulin ; using drugs that lower the blood sugar ; blood pressure and blood fat during the intervention ; use of antibiotics ; the incidence of severe side effects and failure to follow the diet ; non-compliance with the study protocol.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.SUMS.REC.1394.62
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fasting blood sample
Timepoint
The beginning and end of the intervention
Method of measurement
measured by enzymatic spectrophotometry analysis
2
Description
blood pressure
Timepoint
Early intervention-Every tree weeks, once-End of intervention
Method of measurement
mmHg,with an automatic sphygmomanometer
3
Description
lipid profile
Timepoint
The beginning and end of the intervention
Method of measurement
measured by enzymatic spectrophotometry analysis
4
Description
weight
Timepoint
Early intervention-Every tree weeks, once-End of intervention
Method of measurement
seca Scale
5
Description
insulin
Timepoint
The beginning and end of the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
body mass index
Timepoint
The beginning and end of the intervention
Method of measurement
Measured height and weight
2
Description
insulin resistant
Timepoint
The beginning and end of the intervention
Method of measurement
HOMA-IR
Intervention groups
1
Description
Intervention group: soy milk+probiotic cap , a glass of milk ( and a capsule every day for 6 weeks
Category
Treatment - Other
2
Description
Intervention group: soy milk+placebo cap , a glass of milk and a capsule every day for 6 weeks
Category
Treatment - Other
3
Description
Intervention group: probiotic cap , a capsule every day for 6 weeks
Category
Treatment - Other
4
Description
Control group ;milk + placebo , a glass of milk and a capsule every day for 6 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Dr Siavash Babajafari
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Zand Street
City
Shiraz
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 of Shiraz 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
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Siavash Babajafari
Position
Nutrition Phd
Other areas of specialty/work
Street address
Kooye Zahra
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
jafaris@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Siavash Babajafari
Position
Nutrition Phd
Other areas of specialty/work
Street address
Kooye Zahra
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
jafaris@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Azime Hasan poor
Position
Postgraduate Student
Other areas of specialty/work
Street address
Eram Street
City
Shiraz
Postal code
Phone
+98 77 3762 2725
Fax
Email
h.nutritionist@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)