The evaluation of the effects of intermittent fasting diet on clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis
Determining the effects of intermittent fasting on clinical symptoms, inflammation and oxidative stress in postmenopausal, overweight and obese women with rheumatoid arthritis
Design
A clinical trial with a control group, with parallel groups, on 44 patients
Settings and conduct
This study will be conducted as a parallel clinical trial on patients with rheumatoid arthritis. Participants from the rheumatology clinic of Valiasr Hospital in Tehran will be included based on the inclusion criteria. Informed written consent is obtained from the participants, then they are randomly assigned to one of the two groups of 16:8 intermittent fasting diet along with nutritional recommendations based on the permuted block randomization method. The study period will be 8 weeks. At the beginning and end of the study, 10 milliliters of venous blood will be taken from the patients to evaluate biochemical indicators, and also the anthropometric characteristics, food intake and activity and body composition of the patients will be collected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with Rheumatoid Arthritis; menopause; overweight or obese. Exclusion criteria: alcohol consumption; pregnancy; breastfeeding; change in medication regime in the last 3 months.
Intervention groups
The people of the intervention group have an intermittent fasting diet of the type (16:8) in which people are only allowed to receive water and non-energy drinks, tea, coffee and sugar-free gums for 16 hours and for 8 hours In the case of free consumption, they will receive food along with healthy diet recommendations for eight weeks, and the control group will receive their usual diet along with healthy diet recommendations in the same way as the intervention group, for eight weeks. will do
Main outcome variables
Clinical symptoms; inflammation and oxidative stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230217057441N1
Registration date:2023-03-05, 1401/12/14
Registration timing:prospective
Last update:2023-03-05, 1401/12/14
Update count:0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
mahsa ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4223 9415
Email address
mahsa.rnjb99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effects of intermittent fasting diet on clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis
Public title
Evaluation of the effects of fasting diet in patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women
Body mass index 25-35 kg/m2
Age range between 50 and 70 years
Menopause
Diagnosed with rheumatoid arthritis by a rheumatologist for more than 6 months
Moderate to low rheumatoid arthritis disease activity (i.e. disease activity score <5.1)
Following a stable drug regimen for 3 months before the intervention
Not receiving non-steroidal anti-inflammatory drugs (NSAIDs)
Willingness to cooperate
Exclusion criteria:
Consumption of alcohol
Suffering from other autoimmune diseases, kidney diseases, pancreatitis, gallstones, cancer
Pregnancy and breastfeeding
Following a special diet in the last three months
Changing the medication regimen from 3 months
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will using the permuted block technique using 4 blocks, which will be based on the BMI variable and the medications received, and to one of the two groups of 16:8 intermittent fasting diet along with nutritional recommendations to receive healthy food for Rheumatoid arthritis patients and the other group will be assigned a regular diet along with the nutritional recommendations of receiving healthy food for rheumatoid arthritis patients, similar to the recommendations given to the fasting group.
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
Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.376
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
In this study, HAQ score is considered as the primary outcome
Timepoint
Investigating the effects of clinical symptoms, inflammation and oxidative stress at the beginning of the study (before the start of the intervention) and 8 weeks after the start of the intermittent fasting diet in postmenopausal, overweight and obese women with rheumatoid arthritis
Method of measurement
Questionnaire for health assessment-disability index: In order to evaluate the performance of patients, it will be completed by the project manager at the beginning and end of the study, and by asking the patients.
Secondary outcomes
1
Description
The level of total oxidant and antioxidant capacity
Timepoint
The effect of intermittent fasting diet on the level of total oxidant and antioxidant capacity at the beginning of the study (before the start of the intervention) and 8 weeks after the start in postmenopausal, overweight and obese women with rheumatoid arthritis.
Method of measurement
Calorimetry kit: It will be measured from colorimetric methods with microplate spectrophotometer to measure TAC and TOC at the beginning and end of the study.
2
Description
Symptoms of rheumatoid arthritis
Timepoint
The effect of intermittent fasting on the symptoms of rheumatoid arthritis at the beginning of the study (before the intervention) and 8 weeks after the intervention in postmenopausal, overweight and obese women with rheumatoid arthritis.
Method of measurement
Questionnaire to evaluate the degree of swelling and tenderness of joints in rheumatoid arthritis patients, questionnaire of perceived visual pain of the patient, questionnaire of health-disability index, questionnaire to evaluate the level of disease activity by the patient, questionnaire to evaluate the level of disease activity by the researcher, questionnaire to evaluate morning stiffness
3
Description
Inflammation
Timepoint
The effect of intermittent fasting diet on inflammation at the beginning of the study (before the start of the intervention) and 8 weeks after the start in postmenopausal, overweight and obese women with rheumatoid arthritis
Method of measurement
Erythrocyte sedimentation rate or ESR and C-reactive protein or CRP
Intervention groups
1
Description
Intervention group: The people of the intervention group have an intermittent fasting diet of the type (16:8) in which people are only allowed to receive water and non-energy drinks, tea, coffee and sugar-free gums for 16 hours and for 8 hours In the free mode, they will receive food along with healthy diet recommendations for eight weeks
Category
Lifestyle
2
Description
Control group: The control group will receive their usual diet, along with the same healthy diet recommendations as the intervention group, for eight weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kurosh Djafarian
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Futohi
Street address
Tehran Province, Tehran,Keshavarz Blvd., corner of Quds St., Central Organization of the University, 6th floor
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Research assistant of Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Korush Djafarian
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh Djafarian
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Tehran Province, Tehran, Hojjatdoust St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
info_snsd@tums.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