Protocol summary

Summary
Aim of the current study is to investigate relationship between dietary intake of frequently consumed dried fruits in Iran with urinary excretion of 5- Hydroxymethylfurfuraldehyde (HMF), 5-hydroxymethyl-2-furoic acid(HMFA) and 8-Oxo-2'-deoxyguanosine(8-OHdG) among healthy volunteers. The dried fruits selected are currant, apricot, plum, date and fruit bread. The study will be continued for five consecutive weeks. Total of 75 healthy male and female adults aging between 20 and 30 will be invited to participate in the study. Those with any metabolic disorders, autoimmune, chronic renal failure, cancer, neurologic disorders and smokers will be excluded. After an overnight fasting, the participants will be requested to consume100 grams of each dried fruits for five weeks. Two urine samples will be collected from each participant before and 5 five hours after consumption of the dried fruits and will be subjected for HPLC analysis of HMF and HMFA. Also levels of 8-OHdG will be determined using ELISA.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090311288N8
Registration date: 2014-10-04, 1393/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research affairs, Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating relationship between dietary intake of frequently consumed dried fruits in Iran with urinary excretion of 5- Hydroxymethylfurfuraldehyde, 5-hydroxymethyl-2-furoic acid, 8-Oxo-2'-deoxyguanosine
Public title
Food safety issues in dried fruits
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: agreement to participate in the study;subjects with 20-30 years old,No history of food allergies,BMI equal 18.5-25 kg/m2. Exclusion Criteria:any metabolic disorder,autoimmune,chronic,renal failure,cancer ,neurologic disorders,smoking,alcoholics.
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Tabriz University of Medical Sciences
Street address
Vice – Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences,University Daneshgah St, PO Box :51664,
City
Tabriz
Postal code
5166614711
Approval date
2014-01-25, 1392/11/05
Ethics committee reference number
9390

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs

Primary outcomes

1

Description
5- Hydroxymethylfurfuraldehyde
Timepoint
before and 5 hours after consumption of dried fruits
Method of measurement
HPLC

2

Description
5-hydroxymethyl-2-furoic acid
Timepoint
five hours after consuption of dried fruits
Method of measurement
HPLC

3

Description
8-Oxo-2'-deoxyguanosine
Timepoint
before and 5 hours after consumption of dried fruits
Method of measurement
special kits

Secondary outcomes

empty

Intervention groups

1

Description
consumption of 100 g date in the breakfast
Category
Other

2

Description
consumption of 100 g apricot in the breakfast
Category
Other

3

Description
consumption of 100 g currant in the breakfast
Category
Other

4

Description
consumption of 100 g plum in the breakfast
Category
Other

5

Description
consumption of 100 g fruit bread in the breakfast
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nutrition,Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Street address
Department Of Nutrition,Faculty of Nutrition , Tabriz University of Medical Sciences,Ghol-Ghasht st.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for research affairs,Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Med Chem Dept, School of Pharmacy, Tabriz University of Medical Sciences.
City
Tabriz
Grant name
بودجه دانشگاه
Grant code / Reference number
Not Applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research affairs,Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition
Full name of responsible person
Mohammad Alizadeh
Position
Assistant Professor of Nutrition, Ph.D., M.D
Other areas of specialty/work
Street address
Department Of Nutrition, Faculty Of Nutrition,Tabriz University of Medical Sciences ,Gholghasht st.
City
Tabriz
Postal code
5166614711
Phone
+98 41313357313
Fax
+98 41 3334 4731
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir

Person responsible for updating data

Contact

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
empty
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