Evaluation of the efficacy of high protein high calorie diet include L-Arginine, L-Glutamine and β-Hydroxy β-Methylbutyrate on pressure ulcers and anthropometric indices in 20-50 years adults
Evaluation of the effectiveness of high-calorie high-protein diet containing L-glutamine, L-arginine and beta hydroxybeta-methyl butyrate on the improvement of compression wounds and anthropometric indicators in people aged 20-20 years in Kermanshah
Design
This study was conducted in a clinical trial with a blinded double-blind, 42 patient 20-50 years with bedsore who will be randomly assigned to the control and intervention groups.
Settings and conduct
This study will be performed on 42 patients aged 20-50 with bed sores in Imam Reza Hospital in Kermanshah for 2 weeks. After explaining the objectives of the research and obtaining conscious consent, the subjects were evaluated for compressive wound condition and anthropometric indicators. Will take. Patients' wound status will be assessed using the Pressure Ulcer Scale for Healing (PUSH) index, and then individuals will be classified into control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 50-20 years and willingness to cooperate in the project by the individual or a family member, not to be under special diets in the last 6 months, not to be infected with endocrine, liver, kidney, thyroid, lack of disease Taking steroid or hormonal medications.
Exclusion criteria: undergoing surgery in the last 2 weeks
Intervention groups
Intervention group: on a high-protein-high-calorie diet with two sachets per day (noon and evening) of dietary supplements containing L-glutamine, L-arginine and beta-hydroxybeta-methyl butyrate (each 26-gram sachet containing 7.3 g of carbohydrates, 7 Grams of L-arginine, 7 grams of L-glutamine and 1.5 grams of calcium beta-hydroxybeta-methyl butyrate) and control group: will be on a high-protein-high-calorie diet with placebo consumption.
Main outcome variables
The degree of bed sore
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181111041611N4
Registration date:2020-07-09, 1399/04/19
Registration timing:prospective
Last update:2020-07-09, 1399/04/19
Update count:0
Registration date
2020-07-09, 1399/04/19
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of high protein high calorie diet include L-Arginine, L-Glutamine and β-Hydroxy β-Methylbutyrate on pressure ulcers and anthropometric indices in 20-50 years adults
Public title
Evaluation of the efficacy of high protein high calorie diet include L-Arginine, L-Glutamine and β-Hydroxy β-Methylbutyrate on pressure ulcers and anthropometric indices in 20-50 years adults in Kermanshah.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not being on special diets for the past 6 months
Lack of endocrine, hepatic, renal and thyroid disease
Do not take steroid or hormonal medications
Exclusion criteria:
Not having surgery in the last 2 weeks
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization tool: sealed envelope
In this way, by attending the hospital, patients with the criteria for entering the study will be selected and 42 of them will be selected for the intervention and control groups in sealed envelope method. In this way, we first call the intervention group "a" and the control group" b". Then we write the names of the patients in separate envelopes and number them; in the next step, the envelopes with the even numbers will receive the intervention "a" and the envelopes with the odd numbers will receive the intervention "b" or vice versa. It should be noted that we will not know the names inside the envelope when counting the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researchers and participants will not be aware of the allocation of groups, and the supplements appearance will be similar in both groups. The supplemented manufacturer will encoded the supplements before delivery.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.KUMS.REC.1399.362
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bed sores status
Timepoint
Before the start of the study, 2 weeks after the start of the intervention
Method of measurement
Patients' wound status will be assessed using the Pressure Ulcer Scale for Healing Index.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Under a high-protein, high-calorie diet, along with two sachets per day (noon and evening) of dietary supplements containing L-glutamine, L-arginine and beta-hydroxybeta-methyl butyrate prepared by Karen Company of Iran (26 grams per sachet including 7.3 Grams of carbohydrates, 7 grams of L-arginine, 7 grams of L-glutamine and 1.5 grams of calcium beta hydroxy beta methyl butyrate)
Category
Treatment - Other
2
Description
Control group:Under a high-protein, high-calorie diet with placebo consumption
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Karam Ahmadian
Street address
Gomrek Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714897767
Phone
+98 83 3823 0218
Fax
Email
shimamoradi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building No. 2, Research Council Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 6892
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Above Farabi Hospital, Iesar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Above Farabi Hospital, Iesar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Kamari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Num 11, Atlasi 28, Maskan
City
Kermanshah
Province
Kermanshah
Postal code
6715999477
Phone
+98 83 3421 0283
Email
Kamari.negin72@gmail.com
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
Trail that began to fall ill on 22 Th. August of 2020 should have a release plan when recording its study protocol
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
Undecided - It is not yet known if there will be a plan to make this available