Identification and modification of rheological properties of beverages, desserts, and food in patients with esophagus cancer dysphagia and assessment of the rheological modification on improving nutritional indices and quality of life in these patients
The purpose of present study is the modification of rheological properties of beverages, desserts, and foods for dysphagic patients. 40 patients of Atrak clinic (who are in the second phase of esophagus cancer) are divided into two groups. First group are using their conventional diet and the second group uses modified foodstuffs. The effect of the rheological modification on improving nutritional status and the quality of life in these patients will be assessed in an open-label clinical trial, after 3 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072410380N1
Registration date:2012-12-18, 1391/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-18, 1391/09/28
Registrant information
Name
Azizollaah Zargaraan
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 3175
Email address
aziz.zargaran@gmail.com
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute
Expected recruitment start date
2012-09-09, 1391/06/19
Expected recruitment end date
2012-11-09, 1391/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Identification and modification of rheological properties of beverages, desserts, and food in patients with esophagus cancer dysphagia and assessment of the rheological modification on improving nutritional indices and quality of life in these patients
Public title
Identification of rheological properties of desirable foodstuffs for Iranian dysphagic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who have esophageal dysphagia (from esophageous cancer); patients are in the second phase of esophageous cancer (starting chemotrapy). Exclusion criteria: the tendency of samples to exclude from study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
No. 7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741
City
Tehran
Postal code
1981619573
Approval date
2012-12-02, 1391/09/12
Ethics committee reference number
047474
Health conditions studied
1
Description of health condition studied
dysphagia
ICD-10 code
R13
ICD-10 code description
Difficulty in swallowing
Primary outcomes
1
Description
percentage of body weight loss(%BWL)
Timepoint
at the start and 3 monthes after intervention
Method of measurement
scale
2
Description
triceps(TSF) and subscapular skin fold(SSF)
Timepoint
at the start and 3 monthes after intervention
Method of measurement
caliper
3
Description
mid arm circumference(MAC)
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Tape Measure
4
Description
arm muscle circumference(AMC)
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Tape Measure
5
Description
Serum Total Proteins
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Electrophoresis
6
Description
Serum C-reactive protein
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Elisa
7
Description
Albumin
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Elisa
8
Description
Transferrin
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Electrophoresis
9
Description
Pre-Albumin
Timepoint
at the start and 3 monthes after intervention
Method of measurement
Electrophoresis
10
Description
Hematocrit
Timepoint
at the start and 3 monthes after intervention
Method of measurement
coagulation
11
Description
Total Lymphocyte
Timepoint
at the start and 3 monthes after intervention
Method of measurement
microscopic
12
Description
Prognostic Nutritional Index (PNI)
Timepoint
at the start and 3 monthes after intervention
Method of measurement
158 - 16.6(Alb) - 0.78(Ts) - 0.20(Trn) - 5.8(DH)
Secondary outcomes
1
Description
appetite
Timepoint
at the start and 3 month after intervention
Method of measurement
questionnaire
2
Description
Energy intake
Timepoint
at the start and 3 month after intervention
Method of measurement
questionnaire
3
Description
Micronutrient intake
Timepoint
at the start and 3 month after intervention
Method of measurement
questionnaire
4
Description
macronutrient intake
Timepoint
at the start and 3 month after intervention
Method of measurement
questionnaire
5
Description
Quality of life
Timepoint
at the start and 3 month after intervention
Method of measurement
questionnaire
6
Description
enjoyment from foodstuffs
Timepoint
3 month after intervention
Method of measurement
vas
Intervention groups
1
Description
Intervention group uses the rheologically modified foodstuffs, along with common diet (one product from each item)
Category
Treatment - Other
2
Description
control group: there isnt any intervention
they use their conventional diet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Atrak Clinic
Full name of responsible person
Dr. Reza Malekzadeh
Street address
No 1, Sayyad-e-shirazi highway, Gonbad-e-kavous
City
Gonbad-e-kavous
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Research Institute
Full name of responsible person
Dr. Hajifaraji
Street address
No. 7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741
City
Tehran
Grant name
10533
Grant code / Reference number
474
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Research Institute
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
National Nutrition and Food Technology Research Institute
Full name of responsible person
Azizollaah Zargaraan
Position
Ph.d Student
Other areas of specialty/work
Street address
No.7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741
City
Tehran
Postal code
1981619573
Phone
+98 21 4467 3175
Fax
+98 21 2236 0657
Email
aziz.zargaran@gmail.com ; zargaraan@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr. M.A Mohammadifar
Position
Ph.D
Other areas of specialty/work
Street address
No. 7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741
City
Tehran
Postal code
1981619573
Phone
+98 21223690658
Fax
+98 21 2236 0657
Email
mohamdif@ut.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Azizollaah Zargaraan
Position
Ph.D student
Other areas of specialty/work
Street address
No. 46, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741
City
Tehran
Postal code
1981619573
Phone
+98 21 4467 3176
Fax
+98 21 2236 0657
Email
aziz.zargaran@gmail.com , zargaraan@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)