Arthritis, Rheumatoid Clinical Trial
— PIRAOfficial title:
Postprandial Inflammation in Rheumatoid Arthritis
NCT number | NCT04247009 |
Other study ID # | PIRA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2020 |
Est. completion date | November 17, 2021 |
Verified date | December 2021 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with RA will be studied to see whether meals of different content will affect inflammation and metabolic variables in the postprandial state. Healthy controls will also be invited to examine potentially different responses to patients with RA.
Status | Completed |
Enrollment | 56 |
Est. completion date | November 17, 2021 |
Est. primary completion date | November 17, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria for patients with RA: - Diagnosed with rheumatoid arthritis - BMI 18.5-30.0 kg/m2 - 2 years or more since diagnosis - No DMARD changes during the last 3 months Inclusion Criteria for healthy controls: - Absence of diagnosis of RA - BMI 18.5-30.0 kg/m2 - Self-assessed as healthy Exclusion Criteria: - Diagnosis of cancer, inflammatory bowel disease, celiac disease, diabetes - Allergy or intolerance to any of the foods in the study - Pregnancy or breastfeeding - Use of any blood lipid lowering medication, glucocorticoids or IL-6-inhibitor during the last 4 weeks prior to enrolment - Smoking - Hemoglobin < 100 g/L |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Göteborg | Not In US/Canada |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circulating interleukin 6 | Changes from fasting to postprandial | From baseline up to 5 hours postprandial | |
Primary | Circulating high sensitive C-reactive protein (CRP) | Changes from fasting to 5 hours postprandial, area under curve | From baseline up to 5 hours postprandial | |
Primary | Circulating triacylglycerides | Blood lipid levels, Area Under curve from fasting to 5 hours postprandial | From baseline up to 5 hours postprandial | |
Primary | Gene expression analysis | Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells | From baseline up to 5 hours postprandial | |
Primary | Serum metabolomics | Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately | From baseline up to 5 hours postprandial | |
Primary | Urine metabolomics | Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately | From baseline up to 5 hours postprandial | |
Secondary | Body composition | Measured by dual energy X-ray technology | Measured at inclusion of trial, expected to be complete within 6 months | |
Secondary | Body composition | measured by electric impedance analysis | Measured at inclusion and during trial, expected to be complete within 1 year | |
Secondary | Resting metabolic rate | measured by indirect calorimetry | through study completion, expected within 1 year | |
Secondary | Glucose | blood glucose levels measured by NMR-analysis | From baseline up to 5 hours postprandial | |
Secondary | Insulin | blood insulin levels measured by NMR-analysis | From baseline up to 5 hours postprandial | |
Secondary | Patient-reported quality of life | Measured by EQ5D-5L questionnaire | through study completion, expected to be complete within 1 year | |
Secondary | Patient-reported health | Measured by the Short Form (SF36) questionnaire | through study completion, expected to be complete within 1 year | |
Secondary | Patient-reported dietary intake | measured by food frequency questionnaire and 4-day food diary | Through study completion, expected to be complete within 1 year | |
Secondary | Patient-reported background and dietary habits | Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health | During trial, expected to be complete within 1 year | |
Secondary | Patient-reported disability | Health Assessment Questionnaire, disability index (HAQ) | During trial, expected to be complete within 1 year |
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