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Search / Trial NCT05785884

Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 14, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Diet Chronic Pain Knee Osteoarthritis Racial Differences

ClinConnect Summary

This clinical trial is exploring how different diets can affect pain and quality of life in people with knee osteoarthritis (OA). Specifically, it is looking at the effects of a low-carbohydrate diet compared to a standard diet, focusing on how these diets might work differently for Black and White individuals. Researchers want to see if the low-carbohydrate diet can help reduce pain and improve daily living, particularly for those who are Non-Hispanic Black, as they often experience more severe pain and disability from OA.

To be eligible for this study, participants should be between 40 and 75 years old, have a diagnosis of knee OA, and experience pain on most days of the week. They should also consume a significant amount of carbohydrates daily and self-identify as either Non-Hispanic Black or Non-Hispanic White. Participants will be asked to follow one of the diets and report on their pain and overall well-being. This trial is important because it aims to find safe, effective alternatives for pain relief that consider racial differences in health outcomes. If you're interested in participating, you'll be contributing to valuable research that could improve treatment for knee OA in your community.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. diagnosis of knee OA
  • 2. pain in at least 4/7 days/week for the past 3 months (pain of ≥3/10 on 0-10 scale)
  • 3. age between 40-75
  • 4. average daily consumption of \>100 g carbohydrates (based on Phase 1 food checklist)
  • 5. understanding of verbal and written English
  • 6. self-identification as either NHB or NHW
  • 7. BMI between 25 and 40 kg/m2
  • Exclusion Criteria:
  • 1. unmedicated diabetes
  • 2. unwillingness to follow prescribed diets
  • 3. recent weight change (\>4 kg in past month)
  • 4. currently on a diet
  • 5. history of eating disorders or other psychiatric disorders requiring hospitalization within the past 6 months
  • 6. digestive diseases
  • 7. difficulty chewing or swallowing
  • 8. reliance on others for meal preparation
  • 9. cardiovascular or pulmonary disease
  • 10. daily opioid pain medications
  • 11. use of medications known to alter metabolism or digestion (e.g., proton-pump inhibitors)
  • 12. use of anti-hypertensive medications that affect glucose tolerance
  • 13. use of tobacco
  • 14. participation in extreme exercise
  • 15. knee replacement

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Robert E Sorge, PhD

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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