Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
CompletedNot applicableNCT04343716
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. African-Americans (AAs) report greater OA-related disability and pain severity compared to their Non-Hispanic White (NHW) counterparts. These disparities are reinforced through social and biological mechanisms, ultimately resulting in dramatic racial disparities in pain experience and associated quality of life. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, but significant racial differences exist in metabolism that are rarely addressed in diet interventions. The overall objective of the proposed study is to determine whether the beneficial effects of an LCD for knee OA pain are related to race. The investigators will recruit 20 adult women (65-75) with knee OA with equal representation across racial groups (10 AA, 10 NHW). Following one week of diet and pain self-report, the investigators will assess quality of life, depression, experienced pain and evoked pain. Participants will be placed on a LCD wherein all meals and snacks will be delivered weekly after consult with study personnel. Participants will return every 3 weeks for testing during the 6-week intervention with blood drawn at baseline and at the conclusion of the 6-week diet. Blood will be assayed for oxidative stress markers. This will be the first assessment of racial differences in the efficacy of a LCD to reduce knee OA pain. Objective 1: To determine whether the LCD reduces pain after 6 weeks. Hypothesis: The LCD will significantly reduce evoked and self-reported pain. Objective 2: To determine whether the benefits of the LCD differ based on race. Hypothesis 1: The LCD will reduce evoked and self-reported pain more in AA than in NHW. Hypothesis 2: AAs will experience greater improvements in depression, quality of life, pain interference and show more weight loss than NHWs. Objective 3: To determine whether the LCD has a differential impact on oxidativ…
Study details
- Official title
- Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
- Conditions
- Interventions
- Behavioral: Low-carbohydrate diet
- Sponsor
- University of Alabama at Birmingham
- Collaborators
- National Institute on Aging (NIA)
- Start date
- 2020-10-01
- Primary completion
- 2023-09-18
- Sex
- Female
- Age range
- from 65 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. diagnosis of knee OA 2. pain in at least 4/7 days/week for the past 3 months 3. age between 65-75 4. average daily consumption of \>100 g carbohydrates 5. understanding of verbal and written English 6. self-identification as either AA or NHW 7. BMI between 25 and 40 kg/m2 Exclusion Criteria: 1. 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 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04343716