1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of the effect of real oat bread with "oat bread" offered in Tehran on serum glucose and lipid profile in dyslipidemics and type II diabetics
Protocol summary
Summary
This trial investigated whether oat bread can favorably reduce fasting blood glucose and insulin levels and also modify lipid profiles compare to commonly used barley in diagnosed type 2 diabetic and hyperlipidemic patients. A double blind crossover study was conducted on 36 diabetic and dyslipidemic patients with no cardiovascular and systemic diseases or diabetics taking insulin were randomly assigned into two oat and barley bread group.
Patients were given daily 250g oat or barley bread for 3 weeks. 5ml venous fasting blood samples were collected for determining glucose, insulin and lipid profiles at the beginning, after 10 days and the end of the phase. All patients were left for a 3 weeks washout period having their ordinary diet. Then subjects were crossed into another group and the same procedure was repeated for the next phase. To control the dietary intake a 24 hr recall questionnaire was completed for each subject at the first, 10th and 21st day of each phase.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT138711071597N1 Registration date: 2010-01-04, 1388/10/14 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2010-01-04, 1388/10/14 Registrant information
Name
Majid Hajifaraji
Name of organization / entity
National Nutrition & Food Technology Research Institute of IRAN (NNFTRI)
Country
Iran (Islamic Republic of) Phone
+98 21 2236 0661 Email address
[email protected] Recruitment status
Recruitment complete Funding source
National Nutrition & Food Technology Research Institute of IRAN
Expected recruitment start date 2008-11-21, 1387/09/01
Expected recruitment end date 2009-08-23, 1388/06/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparison of the effect of real oat bread with "oat bread" offered in Tehran on serum glucose and lipid profile in dyslipidemics and type II diabetics
Public title
The effect of real oat bread with barley bread on serum glucose and lipid Levels in dyslipidemia and type II diabetes
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Fasting blood glucose >
126 mg/dl and at least one of lipids profile out of normal
2 range Exclusion criteria: Patients with Cardiovascular and
other systemic diseases and IDMM patients taking insulin Age
From 18 years old to 65 years old Gender
Both Phase
2
Groups that have been masked No information
Sample size
Target sample size:
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Not used Assignment
Crossover
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition & Food Technology Research Institute of IRAN
Street address
46 West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City Tehran Postal code
1981619573 Approval date
2009-05-03, 1388/02/13
Ethics committee reference number 5814
Health conditions studied
1
Description of health condition studied Diabetes
ICD-10 code E11, E12
ICD-10 code description
Non-insulin-dependent diabetes mellitus, Malnutrition- related diabetes mellitus
2
Description of health condition studied Dyslipidemia
ICD-10 code E708.0,E78
ICD-10 code description
Pure hypercholesterolaemia, Other hyperlipidaemia, Hyperlipidaemia, unspecified, Lipoprotein deficiency, Other disorders of lipoprotein metabolism, Disorder of lipoprotein metabolism, unspecified
Primary outcomes
1
Description
Serum glucose levels Timepoint
0, 10 days after intervention Method of measurement
Taking 5 ml fasting venous blood sample, Centrifuging samples, determining serum glucose by glucose oxidase using Auto analyzer
2
Description
serum insuline levels Timepoint
0, 10 days after intervention Method of measurement
Taking 5 ml fasting venous blood sample, Centrifuging samples, determining serum Insulin levels using Radioimmunoassay
Secondary outcomes
1
Description
fasting serum insulin levels Timepoint
0, 10, 21 days after intervention Method of measurement
Taking 5 ml fasting venous blood sample, Centrifuging samples, determining serum Insulin levels using Radioimmunoassay
2
Description
serum lipid profiles Timepoint
0, 10, 21 days after intervention Method of measurement
Taking 5 ml fasting venous blood sample, Centrifuging samples, determining serum lipid profiles using Auto analyzer
3
Description
3 Insulin resistance
Timepoint
0, 10, 21 days after intervention Method of measurement
Computing insulin resistance using HOMA:
(FBS*FIns)/22.5
Intervention groups
1
Description
250 g daily oat bread to patients within 3 weeks during the related phase of study consumed during the day and different meals.
Category Other
2
Description
250 g daily barley bread to patients within 3 weeks during the related phase of study consumed during the day and different meals.
Category Other
Recruitment centers
1
Recruitment center
Name of recruitment center Diabetes Society of Iran
Full name of responsible person Dr A Rajab
Street address
No. 46, Malakouti st., Patris Lomomba Ave., Satarkhan Ave.
City Tehran
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
National Nutrition & Food Technology Research Institute of IRAN
Full name of responsible person Dr A Dorosty
Street address
46 West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition & Food Technology Research Institute of IRAN
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
Deputy for Food and Drug – Shahid Beheshti University of Medical Sciences
Full name of responsible person
ُShajieh Najar-Safari Position
MSc in Nutrition; Senior expert of Food Control Division
Other areas of specialty/work Street address
City Tehran Postal code Phone
+98 21 8874 5315 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition & Food Technology Research Institute of IRAN
Full name of responsible person Dr Majid Hajifaraji
Position
PhD in Clinical Nutrition Other areas of specialty/work Street address
46 West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City Tehran Postal code
1981619573 Phone
+98 21 2208 6349 Fax
+98 21 2237 6470 Email
Web page address www.nnftri.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
National Nutrition & Food Technology Research Institute of IRAN
Full name of responsible person Dr Majid Hajifaraji
Position
PhD in Clinical Nutrition Other areas of specialty/work Street address
46 West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City Tehran Postal code
1981619573 Phone
+98 21 2208 6349 Fax
+98 21 2237 6470 Email
[email protected] Web page address
www.nnftri.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
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