Assessment of the effects of Mediterranean and low fat diets compared with regular diet on improvement of symptoms in patients with rheumatoid arthritis
- determination and compare of the effect of Mediterranean, low fat and conventional diet on weight and pain severity in patients with rheumatoid arthritis (RA).
Design
one-arm blinded parallel randomized clinical trial was done on 168 patients were categorized to Mediterranean, low fat and conventional diet for 3 month.
Settings and conduct
the present study is a one-arm blinded randomized feeding trial on 168 patients with rheumatoid arthritis (according to the American Rheumatologic association) at the Zanjan city with the mean age of 15-75 yrs. Before the study enrollment, 3-days food diary record will be filled for dietary intake assessment. The total calorie will considered as 28 kcal/kg. At the Mediterranean diet, 35% of daily calorie will provide from fat, 15% from protein and 50% from carbohydrate. At the low fat diet, 20% of daily calorie will provide from fat, 15% from protein and 65% from carbohydrate.
Participants/Inclusion and exclusion criteria
inclusion criteria
Rheumatoid patients according to the US rheumatologic association criteria
rheumatoid patients at the activated phase of disease, body mass index between 25-35, age of 15-75 yrs, Iranian ethnicity
exclusion criteria
pregnant or lactating women or who decided to pregnant, intake of multivitamins or minerals supplements at least at the last 3 month
people who are on certain diets or have been on a diet for at the last 3 month
people who don't follow the prescribed diets
recent weight loss more than 4 kg during the last 2 month
allergy and sensitivity to fish or impossibility of consuming it
opioid consumption or non-steroid anti-inflammatory drugs on a daily and continuous basis, intake of alcohol and cigarette, maldigesting diseases such as celiac and steatorrhea
Intervention groups
Mediterranean diet low fat diet conventional diet
Main outcome variables
Weight, DAS28 index, VAS index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200929048876N2
Registration date:2020-10-09, 1399/07/18
Registration timing:retrospective
Last update:2020-10-09, 1399/07/18
Update count:0
Registration date
2020-10-09, 1399/07/18
Registrant information
Name
Seyedeh Neda Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6300
Email address
neda.mousavi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
2020-02-19, 1398/11/30
Actual recruitment end date
2020-07-20, 1399/04/30
Trial completion date
2020-09-20, 1399/06/30
Scientific title
Assessment of the effects of Mediterranean and low fat diets compared with regular diet on improvement of symptoms in patients with rheumatoid arthritis
Public title
Useful Diet in patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rheumatoid patients according to the US rheumatologic association criteria
rheumatoid patients at the activated phase of disease
body mass index between 25-35
age of 15-75 yrs
Iranian ethnicity
Exclusion criteria:
pregnant or lactating women or who decided to pregnant
intake of multivitamins or minerals supplements at least at the last 3 month
people who are on certain diets or have been on a diet for at the last 3 month
people who don't follow the prescribed diets
recent weight loss more than 4 kg during the last 2 month
allergy and sensitivity to fish or impossibility of consuming it
opioid consumption or non-steroid anti-inflammatory drugs on a daily and continuous basis
patients at the remission phase of disease
other chronic diseases except of rheumatoid arthritis
intake of alcohol and cigarette
maldigesting diseases such as celiac and steatorrhea
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
168
Actual sample size reached:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will be used as three groups with 15-number blocks including 5 participant in each group. randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment. At this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Nutritionist and patients are aware of grouping. The outcome analyzer will be blinded and has no knowledge about grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Zanjan University of Medical Sciences
Street address
Azadi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2020-01-16, 1398/10/26
Ethics committee reference number
IR.ZUMS.REC.1398.425
Health conditions studied
1
Description of health condition studied
rheumatoid arthiritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Weight changes
Timepoint
baseline and after 3month
Method of measurement
scale
2
Description
pain severity
Timepoint
baseline and after 3 month
Method of measurement
VAS and DAS28 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mediterranean diet which contains 35% of calorie from fats, 15% from protein and 50% from carbohydrates. This diet contains 27-37 gr fiber per day. After calorie counting and dividing the calories according to the above percent, the patients emphasis to receive at least half of their grain and bread from whole form. They can eat 1 time red meat (150 gr) at each month. Their daily oil consumption is olive oil (for salad) and canola oil (for frying).The main meat is white meat and receive 2 capsules of omega-3 each week. At least, one unit of legumes (half a glass of cooked beans) and nuts will be included in the daily diet. Dairy is as low fat and 6 glass of water will consume each day.
Category
Rehabilitation
2
Description
Intervention group: low fat diet which contains 20% of calorie from fats, 15% from protein and 65% from carbohydrates. In this dietary pattern, we will not have any specific recommendation for patients and only required dietary servings for each patient will be determined according the above percent and will be provided for each patient.
Category
Rehabilitation
3
Description
Control group: conventional group without any changes in dietary patterns of participants.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie-Asr Haspital
Full name of responsible person
ِDr. Alireza Sadeghi
Street address
Shariati St
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
sadeghi_alireza50@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Azadi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6400
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Tabatabaiee Befroodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Valie-Asr Hospital, Shariati St
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
mojtabaaatabatabaeee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Tabatabaiee Befroodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Valie-Asr Hospital, Shariati St
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
mojtabaaatabatabaeee@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
13th St, Mahdavi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
neda.mousavi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
without participant name
When the data will become available and for how long
after study final
To whom data/document is available
all persons
Under which criteria data/document could be used
all persons
From where data/document is obtainable
Zanjan University of Medical Sciences, Deputy of Research and Thechnology
What processes are involved for a request to access data/document
straight referee to Deputy of Research and Technology of Zanjan University of Medical Sciences