Diet changes for managing knee pain based on race
Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain
NA · University of Alabama at Birmingham · NCT05785884
This study is testing if a low-carbohydrate diet can help reduce knee pain in adults with osteoarthritis, focusing on differences between Black and White participants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05785884 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-carbohydrate diets on knee osteoarthritis pain, focusing on racial differences in pain experience. It aims to recruit 200 adults aged 40-75, with equal representation of Non-Hispanic Black and Non-Hispanic White participants, who report significant pain and impairment due to knee osteoarthritis. Participants will be screened for eligibility based on their pain levels, dietary habits, and other health factors. The study will compare the outcomes of a low-carbohydrate diet against a standard USDA diet to determine the effectiveness of dietary interventions in reducing pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 with a diagnosis of knee osteoarthritis and significant pain levels.
Not a fit: Patients with unmedicated diabetes, recent weight changes, or those on specific medications affecting metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to pain management for individuals with knee osteoarthritis, particularly in underserved racial groups.
How similar studies have performed: While dietary interventions for pain management have been explored, this specific focus on racial differences and low-carbohydrate diets is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Robert E Sorge, PhD — University of Alabama at Birmingham
- Study coordinator: Robert E Sorge, PhD
- Email: rsorge@uab.edu
- Phone: 12059348563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, diet, chronic pain, knee osteoarthritis, racial differences