Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
Public ClinicalTrials.gov record NCT04343716. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 oxidative stress by race. Hypothesis 1: The LCD will significantly reduce oxidative stress over 6 weeks. Hypothesis 2: AAs will show greater reductions in oxidative stress than NHWs. The reduction in oxidative stress will be correlated with reduction in evoked pain.
Study identification
- NCT ID
- NCT04343716
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2020
- Primary completion
- Sep 17, 2023
- Completion
- Sep 17, 2023
- Last update posted
- Aug 12, 2026
2020 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04343716, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04343716 live on ClinicalTrials.gov.