Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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This study was done in clinic.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Patients will be assigned to receive spirulina supplements (n=40) and placebo (n=40)
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Main outcome variables
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ESR inflammatory markers, oxidative stress markers and serum pentraxin 3 levels.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191204045612N1
Registration date:
2020-01-15, 1398/10/25
Registration timing:
registered_while_recruiting
Last update:
2021-04-05, 1400/01/16
Update count:
1
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Registration date
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2020-01-15, 1398/10/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-04, 1398/10/14
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Expected recruitment end date
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2021-01-03, 1399/10/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effects of Spirulina supplementation on ulcerative colitis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-25, 1398/07/03
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.436
Health conditions studied
1
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Description of health condition studied
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Ulcerative colitis patients
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ICD-10 code
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K51.9
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ICD-10 code description
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Ulcerative colitis, unspecified
Primary outcomes
1
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Description
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Pentraxin 3
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Eliza kit
2
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Description
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Total antioxidant capacity
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
3
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Description
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Malondialdehyde
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
4
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Description
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Superoxide dismutase
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Diagnostic kit
5
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Description
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Erythrocyte Sedimentation Rate
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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Measurement of erythrocyte sedimentation rate
6
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Description
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Disease activity indices
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Timepoint
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Before intervention and 8 weeks after initiation of Spirulina supplementation
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Method of measurement
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SCCAI questionnaire
Secondary outcomes
1
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Description
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Weight
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Use scales
2
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Description
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Body mass index
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Calculation
3
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Description
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Waist
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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measurement
4
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Description
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Neck circumference
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Measurement
5
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Description
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Hip circumference
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Measurement
6
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Description
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Blood pressure
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Measurement
7
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Description
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Dietary intake
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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24-h recall
8
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Description
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Fatigue
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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FSS questionnaire
9
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Description
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Physical activity
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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IPAQ questionnaire
10
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Description
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Quality of life
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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SIBDQ-9 questionnaire
11
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Description
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Sleep Quality
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
12
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Description
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Sleep duration
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
13
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Description
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Subjective sleep quality
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
14
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Description
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Sleep latency
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
15
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Description
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Sleep efficiency
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
16
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Description
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Sleep disturbances
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
17
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Description
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Use of sleep medication
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
18
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Description
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Day-time dysfunction
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
19
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Description
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Depression status
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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DASS 21 questionnaire
20
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Description
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Stress status
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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DASS 21 questionnaire
21
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Description
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Anxiety status
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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DASS 21 questionnaire
22
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Description
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Stool frequency
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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SIBDQ-9 questionnaire
23
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Description
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Bowel distress and cramp
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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SIBDQ-9 questionnaire
24
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Description
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Gas excretion of bowel
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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SIBDQ-9 questionnaire
25
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Description
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Flatulence
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Timepoint
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Before intervention and 8 weeks after initiation of spirulina supplementation
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Method of measurement
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SIBDQ-9 questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Isfahan university of medical science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available