Protocol summary

Study aim
Determining the effect of nightshade elimination diet on inflammatory and rheumatological factors of rheumatoid arthritis patients
Design
single blind parallel randomized clinical trial
Settings and conduct
In this study, people are randomly divided into two intervention and control groups (18 people in each group). Block randomization will be implemented, so that there are 2 blocks in each group (each block contains 9 patients), which are divided based on gender and body mass index. Both groups will receive general dietary recommendations and intervention group also receive nightshade elimination diet for 8 weeks.
Participants/Inclusion and exclusion criteria
age over 18 years, definitive diagnosis of the disease by a doctor using the criteria of the American College of Rheumatology (ACR), not taking any nutritional supplements, not having a diet during the study and before sampling,the criteria for not entering the study: others Chronic diseases: allergy, CVD, asthma, cancer, depression, Alzheimer's, psychoactive drugs, simultaneous disorder of RA with other rheumatoid diseases and exclusion criteria: smoking, changing therapeutic drugs, taking nutritional supplements, suffering from any type of disease Other during the study are non-compliance with the study protocol, the occurrence of serious complications during the study.
Intervention groups
In order to comply with ethics in the research, both groups of patients will receive an general dietary recommendations for 8 weeks (two months), and patients in the intervention group, in addition to these recommendations, will also receive a nightshade elimination diet. In this way, patients are asked to avoid consuming any nightshade vegetables, including tomatoes, eggplants, potatoes, and peppers in any form
Main outcome variables
Anthropometric parameters, demographic information, inflammatory and rheumatological indices, clinical outcomes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230220057465N1
Registration date: 2023-04-08, 1402/01/19
Registration timing: prospective

Last update: 2023-04-08, 1402/01/19
Update count: 0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Mahboobe Hosseinikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5519
Email address
m.hosseinikia@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of nightshade elimination diet on inflammatory and rheumatologic markers of rheumatoid arthritis patients: single blind randomized clinical trial
Public title
nightshade elimination diet on arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age over 18 years confirmed diagnosis of the disease by a doctor using the criteria of the American College of Rheumatology (ACR) not taking any nutritional supplements not having a diet during the study and before sampling
Exclusion criteria:
others Chronic diseases: allergy, CVD, asthma, cancer, depression, Alzheimer's psychoactive drugs consumption simultaneous disorder of RA with other rheumatoid diseases smoking changing therapeutic drugs taking nutritional supplements non-compliance with the study protocol occurrence of serious complications during the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be implemented using statsdirect.com, so that there are 2 blocks in each group (each block contains 9 patients), which are divided based on gender and body mass index (BMI).
Blinding (investigator's opinion)
Single blinded
Blinding description
study goals and study process will be explained to participants. General recommendations regarding dietary observances will be given to both groups. But, intervention group receive nightshade elimination diet.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Golestn 15th
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.YUMS.REC.1401.172

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.8
ICD-10 code description
Other specified rheumatoid arthritis

Primary outcomes

1

Description
Complete Blood Count
Timepoint
at baseline and at the end of treatment ( week 8)
Method of measurement
Cell Counter

2

Description
Hs-CRP
Timepoint
at baseline and at the end of treatment ( week 8)
Method of measurement
ELISA Reader

3

Description
IL-1
Timepoint
at baseline and at the end of treatment ( week 8)
Method of measurement
ELISA Reader

4

Description
ESR
Timepoint
at baseline and at the end of treatment ( week 8)
Method of measurement
Westergren-Katz tube

5

Description
Clinical symptoms
Timepoint
at baseline and at the end of treatment ( week 8)
Method of measurement
Using AIMS-2: Arthritis Impact Measurement Scale-2 by rheumatologist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group will receive general dietary recommendations including reduce consumption of simple sugar, saturated fatty acids, red meat, refined cereals and increase consumption of w-3 and MUFA, whole grains, and night shade elimination diet including elimination of eggplant, tomato, pepper from diet
Category
Treatment - Other

2

Description
Control group will receive general dietary recommendations including reduce consumption of simple sugar, saturated fatty acids, red meat, refined cereals and increase consumption of w-3 and MUFA, whole grains
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Health and Nutrition
Full name of responsible person
Seyed Bahman Panahande
Street address
Golestan 15th
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Phone
+98 74 3322 5519
Email
panahande.b@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hosseini Motlaq
Street address
Motahari BLVD
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Phone
+98 74 3334 6078
Email
research@yums.ac.ir
Web page address
https://research.yums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mahboobe Hosseinikia
Position
Internship instructor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
golestan 15th
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Phone
009874332251
Email
m.hosseinikia@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Bahman Panahande
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan 15th
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Phone
+98 74 3322 5519
Email
panahnde.b@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mahboobe Hosseinikia
Position
Intership instructor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan 15th
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75911875114
Phone
+98 74 3322 5519
Email
m.hosseinikia@yahoo.com

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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
information regarding primary outcomes will be published
When the data will become available and for how long
october2023
To whom data/document is available
data will be available upon request from anyone
Under which criteria data/document could be used
-----
From where data/document is obtainable
please refer to correspond
What processes are involved for a request to access data/document
email to correspond
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