investigating the effect of processed soy bread on serum levels of lipid profile,total antioxidant capacity and inflammatory factors in women with rheumatoid arthritis
Ahvaz University of Medical Sciences, after obtaining a permit to take patients from Dr. Rajaee's office, began by selecting them and randomly divided them into two groups: soy bread and wheat bread. Eat three meals a day with the main meal. The intervention will last 6 weeks. On the day of the initial test in the fasting state, they will be asked to start eating bread and will receive bread every two weeks by going to the office. At the end of the intervention, they went to the lab.
Participants/Inclusion and exclusion criteria
women with active rheumatoid arthritis that dont be in pregnant and lactation condition
Intervention groups
group1: soy bread group2:wheat bread
Main outcome variables
lipid profile, total antioxidant capacity (TAC), tumour necrosis factor-α (TNF-α), c-reactive protein (CRP)
General information
Reason for update
Acronym
RA: rheumatoid arthritis
IRCT registration information
IRCT registration number:IRCT20181021041396N1
Registration date:2020-05-26, 1399/03/06
Registration timing:retrospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Afsane Sayyaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 2887
Email address
afsaneh_sayyaf@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-12, 1398/02/22
Expected recruitment end date
2019-07-03, 1398/04/12
Actual recruitment start date
2019-05-18, 1398/02/28
Actual recruitment end date
2019-07-03, 1398/04/12
Trial completion date
2019-07-06, 1398/04/15
Scientific title
investigating the effect of processed soy bread on serum levels of lipid profile,total antioxidant capacity and inflammatory factors in women with rheumatoid arthritis
Public title
Effect of soy bread on rheumatoid artritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency cooperation with plan
Diagnosis of rheumatoid arthritis
Body mass index less than 35
Exclusion criteria:
smoking
Alcohol consumption
Pregnancy and lactation
Having kidney, liver, gastrointestinal and heart disease and cancer
Allergic reaction to processed foods
Patient cancellation for study collaboration
Changes in the type of medication used daily
Changes in diet or physical activity for any reason
Acceptance of less than 80% of interventions
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, individual
Participants were divided into two groups based on the fact that the last number of their birth dates was odd and even.the persons who have even number, pose into intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, bread packages will be similar, and neither patients nor researchers know the type of packages received. In fact, a third person who knows the content of the packages distributes them among the participants. The form and content of the packages are similar in the two groups, while their nature is different.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Univercity of Medical Sciences
Street address
Esfand Ave.,Golestan Blvd.,Univercity city.,Ahwaz Medical Univercity of Jondishapour
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.AJUMS.REC.1398.135
Health conditions studied
1
Description of health condition studied
Rheumatoid artritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Tumor necros factor Alpha
Timepoint
Before intervention and 6 week after Intervention
Method of measurement
Eliza
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before intervention and 6 week after intervention
Method of measurement
Sampling from blood serum of patients
Intervention groups
1
Description
"Intervention Group:" Consumption of processed soy bread, 90 grams per day, 3 times a day with or before the main meals for 6 weeks, prepared by Sarina Company under the brand name of Dr. SOY, in Iran.
Category
Treatment - Other
2
Description
Control group: Daily consumption of 90 grams of wheat bread for 6 weeks. Prepared by Sarina Company, in Iran