Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain

NCT ID
NCT05785884
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of Alabama at Birmingham
Conditions
Knee Osteoarthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 200 participants (Estimated).

What is being studied

  • Behavioral: Diet
  • Intervention: Diet
  • Intervention: Diet, Food, and Nutrition
  • Intervention: Nutritional Physiological Phenomena
  • Intervention: Physiological Phenomena

Who may be eligible

Ages
40 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Alabama, United States: 1

Sample of listed locations

  • University of Alabama at Birmingham — Birmingham, Alabama, 35294, United States — Recruiting

Study details

Start date
February 1, 2023
Primary completion date
June 30, 2027
Completion date
June 30, 2027
First posted
March 27, 2023
Collaborators
National Institute of Nursing Research (NINR)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05785884
Registry last updated
August 12, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT05785884 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Clinical trial FAQ