Clinical trial Recruiting at 1 site Interventional Ages 40 to 75

Diet changes for managing knee pain based on race

Official title: Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain (DIRECTPain)

Run by University of Alabama at Birmingham · NCT05785884 · Data updated 2026-11-12

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

Study typeInterventional
Ages40 Years to 75 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedAugust 12, 2026
Trial IDNCT05785884 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 40-75 with a diagnosis of knee osteoarthritis and significant pain levels.

Probably not a fit

Patients with unmedicated diabetes, recent weight changes, or those on specific medications affecting metabolism may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.