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Comparing the effectiveness of barley bread enriched with vitamin D microcapsules on serum vitamin D levels, cardiometabolic indices, and kidney function in people with type 2 diabetes.

Protocol summary

Study aim
Determining the effect of consuming barley bread enriched with vitamin D on vitamin D serum level, cardiometabolic indices, and kidney function in people with type 2 diabetes
Design
A clinical trial with an intervention group and control group, with parallel groups, double-blind, randomized, on 130 patients.
Settings and conduct
To enrich barley bread with vitamin D at a dose of 600 international units per gram, we turn this vitamin into microcapsules to increase the stability and solubility of the product; For this purpose, after the production of microcapsules using edible grade wall materials, the size of microcapsules, zeta potential, their solubility, the efficiency of vitamin D encapsulation, the morphology of the capsules and the efficiency of the production process will be evaluated.The place of work is in the food nanotechnology research group of Mashhad Food Science and Industry Research Institute.
Participants/Inclusion and exclusion criteria
Entry conditions include people with type 2 diabetes, and non-entry conditions include the use of drugs that affect vitamin D metabolism; Taking megadose of vitamin D up to 3 months before the start of the intervention or medications that interfere with this vitamin; suffering from endocrine diseases; disorders affecting the metabolism of minerals and vitamin D; They are unusually exposed to sunlight.
Intervention groups
Feeding the intervention group with vitamin D-enriched barley bread and the control group with ordinary barley bread for 4 months
Main outcome variables
Anthropometric indices, cardiometabolic indices, blood pressure, C-reactive protein, blood lipid levels, renal function, serum vitamin D level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221203056695N1
Registration date: 2023-11-08, 1402/08/17
Registration timing: retrospective

Last update: 2023-11-08, 1402/08/17
Update count: 0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Mohamad Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2409
Email address
hashemimd@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-04, 1400/09/13
Expected recruitment end date
2022-05-01, 1401/02/11
Actual recruitment start date
2022-06-10, 1401/03/20
Actual recruitment end date
2022-09-25, 1401/07/03
Trial completion date
2022-12-06, 1401/09/15
Scientific title
Comparing the effectiveness of barley bread enriched with vitamin D microcapsules on serum vitamin D levels, cardiometabolic indices, and kidney function in people with type 2 diabetes.
Public title
Effect of barley bread fortified with vitamin D in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 2 diabetes
Exclusion criteria:
Pregnancy Taking drugs that affect vitamin D metabolism, such as taking a vitamin D supplement of more than 400 units per day Taking megadoses of vitamin D up to 3 months before the start of the intervention or medications that interfere with this vitamin Suffering from endocrine diseases Disorders affecting the metabolism of minerals and vitamin D Exposure to the sun in an unusual way, such as skin tanning
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 130
Actual sample size reached: 130
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and outcome assessor is blinded and assumes that all participants will receive barley bread enriched with microcapsules containing vitamin D, although some will not and will receive barley bread not enriched with vitamin D microcapsules.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qurashi Bldg., Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.MUMS.REC.1395.369

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.8
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications

Primary outcomes

1

Description
Anthropometric indicators
Timepoint
Evaluation of the anthropometric indicators of people before the start of the study and after the end of the intervention.
Method of measurement
Body Analyzer

2

Description
Cardiometabolic indicators
Timepoint
Evaluations related to vitamin D serum level, cardiometabolic indicators, and kidney function at the beginning of the study and the end of the intervention
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Feeding the intervention group with vitamin D-enriched barley bread for 4 months
Category
Placebo

2

Description
Control group: Feeding the control group with ordinary barley bread
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical School
Full name of responsible person
Dr. Mohsen Nemati
Street address
The east door of the university campus, Azadi Sq., Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Fax
+98 51 3882 8560
Email
MDS.Dean@mums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Qurashi Bldg., Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Web page address
https://mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohamad Hashemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Sq., Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2409
Email
hashemimd@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Hashemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Sq., Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2409
Email
hashemimd@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Hashemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Department of Nutrition, Faculty of Medicine, Ferdowsi University Campus, Azadi Sq., Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2409
Email
hashemimd@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the discretion of the project managers, no decision has been taken to publish the patients' information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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