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The effect of anti-inflammatory compared with the low-calorie diet on anthropometric indecies, anxiety, depression, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese women with knee osteoarthritis

Protocol summary

Study aim
Determining the effect of anti-inflammatory in comparison with low caloric diet on anthropometric indices, anxiety, depression, functional status, pain and quality of life, and serum inflammatory and oxidative stress indices in overweight and obese women with knee osteoarthritis
Design
The method of project implementation is randomized clinical trial. The target population in this study was female patients referring to the physical medicine clinic of Imam Reza Hospital in Tabriz with diagnosis of knee osteoarthritis. The final sample size was 60 (30 persons per group).
Settings and conduct
The target population in this study were female patients referring to the physical medicine and rehabilitation clinic of Imam Reza Hospital in Tabriz, with the diagnosis of knee osteoarthritis. Subjects randomly assigned to two groups and then receive the appropriate dietary intervention. Subjects are unaware of the allocation of people to two types of diet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of knee osteoarthritis (mild, moderate), Age 50 and older, BMI 41-27, have cognitive ability to complete nutritional forms Exit criteria: Receiving less than 800 and more than 4200 calories daily calories, intra-articular injection drug use 3 months ago, oral administration (non-steroid anti-inflammatory drugs) one week before entering the study, those who cannot, for any reason. Use of dietary supplements during the intervention period, participation in sports programs or changes in physical activity, illness and the use of drugs that affect weight, do physical therapy in the past 3 months, aggravation of symptoms and pain
Intervention groups
Intervention 1: Balanced dietary intervention (A) Intervention 2: Anti-inflammatory Diet Intervention (B)
Main outcome variables
Quality of Life, Pain, Depression, Stress Oxidation, Inflammatory Indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161022030424N2
Registration date: 2018-04-23, 1397/02/03
Registration timing: registered_while_recruiting

Last update: 2018-04-23, 1397/02/03
Update count: 0
Registration date
2018-04-23, 1397/02/03
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-11-12, 1397/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of anti-inflammatory compared with the low-calorie diet on anthropometric indecies, anxiety, depression, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese women with knee osteoarthritis
Public title
The effect of anti-inflammatory compared with the low-calorie diet on anthropometric indecies, anxiety, depression, functional status, pain and quality of life and serum indices of inflammation and oxidative stress in overweight and obese women with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of knee osteoarthritis by physicians (mild, moderate) Age 50 and older BMI 41-27 Has the cognitive ability to complete the learned forms of food The desire to participate in the study
Exclusion criteria:
Get daily calories less than 800 and more than 4200 kcal Follow a special food pattern for medical reasons or other reasons Infection with other inflammatory diseases, such as rheumatoid arthritis Diabetes Other musculoskeletal problems, including back pain Having a history of radiotherapy Intra-articular intra-articular injection 3 months ago Oral use (nonsteroidal anti-inflammatory drugs) from a week before entering the study Depression (gaining a score of more than 5 from the Geriatric Depression Scale, GDS-15) History of neurological diseases or drug use People who for any reason are not able to cooperate in completing questionnaires and plans Use of dietary supplements, diuretics or laxatives during the intervention period Participate in sports programs or change physical activity Performing physiotherapy in the last 3 months Use of nonsteroidal anti-inflammatory drugs during the study
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization to a low-calorie diet or an anti-inflammatory diet was done by an allocation sequence specified by computerized random-number generation (Blockrand in R version 3.4.0; R Project for Statistical Computing) by a statistician not included in intervention delivery or data collection
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants did not learn of their diet group assignment
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgshest St, Azadi St,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.TBZMED.REC.1396.1117

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Unilateral primary osteoarthritis of knee

Primary outcomes

1

Description
Functional status and pain associated with osteoarthritis in the lower extremities
Timepoint
Before and after the intervention
Method of measurement
Western Ontario and McMaster (WOMAC)

2

Description
BMI
Timepoint
The beginning and the end of the study
Method of measurement
The result of dividing the weight into kilograms by squared height in meters

3

Description
Waist
Timepoint
The beginning and the end of the study
Method of measurement
Strip meter

4

Description
Hip circumference
Timepoint
The beginning and the end of the study
Method of measurement
Strip meter

5

Description
Severity of anxiety
Timepoint
The beginning and the end of the study
Method of measurement
Two-part questionnaire of Spielberger's apparent and hidden anxiety

6

Description
Depression rate
Timepoint
The beginning and the end of the study
Method of measurement
Beck Depression Inventory

7

Description
The amount of pain
Timepoint
The beginning and the end of the study
Method of measurement
VAS (Visual Analogue Scale)

8

Description
Quality of Life
Timepoint
The beginning and the end of the study
Method of measurement
SF-36 quality of life questionnaire

9

Description
Biochemical analysis of blood samples
Timepoint
The beginning and the end of the study
Method of measurement
Biochemical analysis of blood samples

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Balanced diet (A) intervention to reduce the weight of half a kilogram a week will be deducted from the average 3-day energy received by the individual 500 kilocalories and the diet will be designed with the following distribution: Fat: Less than 30% calories, Carbohydrates: 60-55 Percentage of calories and protein: 10-15% calories.
Category
Treatment - Other

2

Description
Intervention group 2: Anti-inflammatory Diet Intervention (B)The anti-inflammatory diet on fresh fruits and vegetables is the largest portion of the diet that should be eaten in large amounts and in each meal, in different types and colors (two-thirds of dietary calories).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Physical and Rehabilitation Sciences Research Center
Full name of responsible person
Neda Dolatkhah
Street address
Physical and Rehabilitation Sciences Research Center, Emam Reza Hospital, Gholgasht St, Azadi St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolgasem Jouyban
Street address
Deputy of Research and Technology, Tabriz University of Medical Sciences, Golghasht St, Azadi St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza Hospital, Golgasht, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Fax
Email
dolatkhahn@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza Hospital, Golgasht, Azadu Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Fax
Email
dolatkhahn@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Emam Reza Hospital, Golgasht, Azadu Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Fax
Email
dolatkhahn@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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