Effect of Spirulina supplement (Arthrospira platensis) on disease activity indices, quality of life, mood, fatigue, serum antioxidant status and serum pentraxin 3 levels in patients with ulcerative colitis
The aim of study is evaluation the effects of spirulina supplementation on disease activity indices, quality of life, mood, fatigue, antioxidant status and serum pentraxin 3 levels (ptx3) in patients with ulcerative colitis
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial. In this study 80 individuals will participate. Patients will be randomly divided into two groups. The first group of patients will receive Spirulina (Arthrospira platensis) 1 g daily and the second group will be age- and sex-matched colitis patients who will be selected as controls and receive placebo. All participants will receive two 500 mg capsules daily. Tests on participants' serum will include: ESR inflammatory markers, oxidative stress markers and serum pentraxin 3 levels.
Settings and conduct
This study was done in clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients included in the study had mild or moderate levels of ulcerative colitis and were between 18 and 65 years of age. Exclusion criteria: Patients with severe ulcerative colitis or other chronic diseases. People during pregnancy or lactation. Smokers or alcohol users. Taking antidepressants and anxiety medications. Taking antioxidant and omega-3 supplements in the last three months.
Intervention groups
Patients will be assigned to receive spirulina supplements (n=40) and placebo (n=40)
Effect of Spirulina supplement (Arthrospira platensis) on disease activity indices, quality of life, mood, fatigue, serum antioxidant status and serum pentraxin 3 levels in patients with ulcerative colitis
Public title
Effects of Spirulina supplementation on ulcerative colitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate ulcerative colitis in the age range of 18 to 65 years
Exclusion criteria:
Patients with severe ulcerative colitis
Individuals in pregnancy or breastfeeding condition.
Taking antidepressants and anxiety medications.
Taking antioxidant and omega-3 supplements in the last three months.
Smokers or alcohol consumers.
Patients with kidney, liver, thyroid and parathyroid, gastrointestinal and heart disease and cancer disease.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method using random number table is used. This method first uses a random number table, which is a set of numbers that have no pattern or order and which is completely generated. The researcher divides these numbers randomly between the intervention and placebo groups. With the presence of clients, the researcher begins to read the numbers in the specified order. Each client receives its own number and is randomly assigned to either the intervention or the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. Given that the researcher and patient should not be aware of the contents of the capsules, the third person places the placebo and spirulina into identical and similar capsules and containers and encodes them randomly. Spirulina and placebo are then presented to the researcher with a code to disclose to the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Hezar jarib
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Approval date
2019-09-25, 1398/07/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.436
Health conditions studied
1
Description of health condition studied
Ulcerative colitis patients
ICD-10 code
K51.9
ICD-10 code description
Ulcerative colitis, unspecified
Primary outcomes
1
Description
Pentraxin 3
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Eliza kit
2
Description
Total antioxidant capacity
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit
3
Description
Malondialdehyde
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit
4
Description
Superoxide dismutase
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Diagnostic kit
5
Description
Erythrocyte Sedimentation Rate
Timepoint
Before intervention and 8 weeks after initiation of Spirulina supplementation
Method of measurement
Measurement of erythrocyte sedimentation rate
Secondary outcomes
1
Description
Weight
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Use scales
2
Description
Body mass index
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Calculation
3
Description
Waist
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
measurement
4
Description
Neck circumference
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Measurement
5
Description
Hip circumference
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Measurement
6
Description
Mood status
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
DASS 21 questionnaire
7
Description
Blood pressure
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Measurement
8
Description
Dietary intake
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
24-h recall
9
Description
Fatigue
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
FSS questionnaire
10
Description
Physical activity
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
IPAQ questionnaire
11
Description
Quality of life
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
SIBDQ questionnaire
12
Description
Disease activity indices
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
SCCAI questionnaire
13
Description
Sleep status
Timepoint
Before intervention and 8 weeks after initiation of spirulina supplementation
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Intervention group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive Spirulina (Arthrospira platensis) 1 g daily (receive two 500 mg capsules daily) for 8 weeks.
Category
Treatment - Other
2
Description
Control group: People entering the study will have mild or moderate level of ulcerative colitis, ranging in age from 18 to 65 years old (n=40). The group of patients will receive starch 1 g daily (receive two 500 mg capsules daily) for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mehdi Zubiri's office
Full name of responsible person
mohammad hassan entezari
Street address
hezar jarib
City
isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Smoradi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
mohammad hassan entezari
Street address
hezar jarib
City
isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
entezari@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan university of medical science
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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hassan entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Phone
009836680048
Email
entezari@hlth.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hassan entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Phone
009836680048
Email
entezari@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hassan entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Phone
009836680048
Email
entezari@hlth.mui.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