NCT04247009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

January 21, 2020

Last Update Submit

March 24, 2025

Conditions

Arthritis, RheumatoidInflammatory ResponseDietary ExposureDiet, Healthy

Keywords

postprandialinflammationrheumatoid arthritisRAdietPIRA

Outcome Measures

Primary Outcomes (6)

  • Circulating interleukin 6

    Changes from fasting to postprandial

    From baseline up to 5 hours postprandial

  • Circulating high sensitive C-reactive protein (CRP)

    Changes from fasting to 5 hours postprandial, area under curve

    From baseline up to 5 hours postprandial

  • Circulating triacylglycerides

    Blood lipid levels, Area Under curve from fasting to 5 hours postprandial

    From baseline up to 5 hours postprandial

  • 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

  • Serum metabolomics

    Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately

    From baseline up to 5 hours postprandial

  • Urine metabolomics

    Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately

    From baseline up to 5 hours postprandial

Secondary Outcomes (10)

  • Body composition

    Measured at inclusion of trial, expected to be complete within 6 months

  • Body composition

    Measured at inclusion and during trial, expected to be complete within 1 year

  • Resting metabolic rate

    through study completion, expected within 1 year

  • Glucose

    From baseline up to 5 hours postprandial

  • Insulin

    From baseline up to 5 hours postprandial

  • +5 more secondary outcomes

Study Arms (4)

Meat

ACTIVE COMPARATOR

Patients with RA served a meal of meat

Other: Meal based on red meat, fish products or vegan productsOther: Meal based on red meat

Fish

ACTIVE COMPARATOR

Patients with RA served a meal of fish

Other: Meal based on red meat, fish products or vegan products

Vegan

ACTIVE COMPARATOR

Patients with RA served a vegan meal

Other: Meal based on red meat, fish products or vegan products

Meat controls

ACTIVE COMPARATOR

Matched controls served a meal of meat

Other: Meal based on red meat

Interventions

Meal based on red meat, fish products or vegan productsOTHER

Three meals will be served

FishMeatVegan
Meal based on red meatOTHER

Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA

MeatMeat controls

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with rheumatoid arthritis
  • BMI 18.5-30.0 kg/m2
  • years or more since diagnosis
  • No DMARD changes during the last 3 months
  • Absence of diagnosis of RA
  • BMI 18.5-30.0 kg/m2
  • Self-assessed as healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Not in US/Canada, 405 30, Sweden

Location

Related Publications (4)

  • Lindqvist HM, Hulander E, Barebring L, Gjertsson I, Winkvist A. A randomized controlled cross-over trial of differences in acute effects on serum metabolites from isocaloric meals based on red meat, fatty fish, or soy protein. Eur J Nutr. 2025 May 26;64(5):187. doi: 10.1007/s00394-025-03710-0.

    PMID: 40418340DERIVED

  • Sallstrom T, Barebring L, Hulander E, Gjertsson I, Winkvist A, Lindqvist HM. Inflammatory and lipemic response to red meat intake in women with and without Rheumatoid Arthritis: a single meal study within a randomized controlled trial. BMC Nutr. 2025 Apr 11;11(1):74. doi: 10.1186/s40795-025-01055-9.

    PMID: 40217385DERIVED

  • Lindqvist HM, Gjertsson I, Hulander E, Barebring L, Winkvist A. Exploring the differences in serum metabolite profiles after intake of red meat in women with rheumatoid arthritis and a matched control group. Eur J Nutr. 2024 Feb;63(1):221-230. doi: 10.1007/s00394-023-03257-y. Epub 2023 Oct 9.

    PMID: 37814020DERIVED

  • Lindqvist HM, Wallengren O, Eriksson A, Hulander E, Winkvist A, Barebring L. Validity of bioimpedance for assessment of fat-free mass in women with Rheumatoid Arthritis compared to non-rheumatic controls. Clin Nutr ESPEN. 2022 Feb;47:333-338. doi: 10.1016/j.clnesp.2021.11.016. Epub 2021 Nov 14.

    PMID: 35063223DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

Fish Products

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SeafoodMeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Helen HL Lindqvist, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 29, 2020

Study Start

February 1, 2020

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Data cannot be shared publicly because of Swedish law. The datasets analysed could be made available from the corresponding author on reasonable request.

Locations

SE(1)