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Recruiting

NCT Number: NCT05559463

Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis

To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

Recruiting

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Monica Guma, MD

CONTACT

[email protected]

Monica Guma, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed of Knee Ostoeaarthritis
  • without changes in treatment in the last 3 months

Exclusion criteria

  • food allergies
  • pregnancy

Treatment and study plan

ITIS diet

Dietary Supplement

anti-inflammatory (ITIS) diet for 28 days

Primary outcomes

  1. Change of baseline pain measured by visual analogue scale (0-10) after 28 days

    Time frame: 28 days

    Change of baseline pain measured by visual analogue scale (0-10) after 28 days, being 0 no pain, and 10 the worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Guma, MD, PhD

CONTACT

[email protected]

8588226523

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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