This pre-post intervention study will be conducted on elderly people living in Thamenolaemeh elderly home with Xerostomy. The purpose of this study is to evaluate the effect of Iranian traditional sorbet on Xerostomy, food intake and body mass index among residence in Thamenolaemeh elderly home. Subjects of the study should have Mini Mental Status Exam score higher that 12 and are able to eat orally independently or with help. Elderly residence who are on Nasogastric tube feeding are excluded from the study. The intervention will be drinking Iranian traditional sorbet two times a day, one hour before lunch and dinner. The study will last for six consecutive weeks and glacial sorbet will be served for elderly people. Subjects will be evaluated for dry moth, food intake and body mass index after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052116285N2
Registration date:2015-06-08, 1394/03/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Ali Dadgari
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
dadgari@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian traditional sorbet on Xerostomy, body mass index and food intake on elderly people in Thamenolaemeh elderly home- Shahroud 1394 HS
Public title
Effect of Iranian traditional sorbet on Xerostomy, body mass index and food intake on elderly people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Being 60 years old and above; hospitalized in elderly home
Exclusion Criteria: Mini mental status score 12 or less; feeding way other than oral
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
7 Tir Sq
City
Shahroud
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SHMU.REC. 1394.33
Health conditions studied
1
Description of health condition studied
Dry Mouth
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
Primary outcomes
1
Description
Food Intake
Timepoint
Before and one week after intervention
Method of measurement
Food intake questionnaire
2
Description
Body Mass Index
Timepoint
Before and one week after intervention
Method of measurement
BMI Scale
3
Description
Xerostomy reduction
Timepoint
Before and one week after intervention
Method of measurement
Xerostomy Scale
Secondary outcomes
empty
Intervention groups
1
Description
In this study, 50ml Iranian glacial sorbet composed of natural fruit juice free of sugar and other synthetic products will be made by sorbet making machine of Danob Company and will be served for 6 consecutive weeks two times a day, one hour before lunch and dinner. In this clinical trial there is no control group and pre-post comparison will be done
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Thamenolaemeh elderly home
Full name of responsible person
Ali Dadgari
Street address
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciemces
Full name of responsible person
Dr Mohammad Mirrezaei
Street address
Shahroud University of Medical Sciences
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciemces
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
Shahroud University of Medical Sciences
Full name of responsible person
Ali Dadgari
Position
PhD Candidate
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences
City
Shahroud
Postal code
Phone
+98 233235054
Fax
Email
adadgari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Dadgari
Position
PhD candidate of Gerontology
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences
City
Shahroud
Postal code
Phone
+98 233235054
Fax
Email
adadgari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Dadgari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
adadgari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)