N/A
Completed N=19
Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
Source: ClinicalTrials.gov NCT04343716 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: WOMAC Pain Change — 1; .7571 WOMAC pain score
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC Pain Change |
1; .7571 | — |
| PRIMARY BPI Pain Change |
4.5; 1.15 | — |
| SECONDARY WOMAC Physical Function |
.375; .8238 | — |
| SECONDARY BPI Pain Interference Change |
2.55; 1.6825 | — |
| SECONDARY TS Pain Intensity Change |
10; -7.8571 | — |
| SECONDARY RCS Pain Intensity Change |
0; 6 | — |
| SECONDARY PHQ-9 Depression Change |
0; 3.5714 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosis of knee OA
- pain in at least 4/7 days/week for the past 3 months
- age between 65-75
- average daily consumption of >100 g carbohydrates
- understanding of verbal and written English
- self-identification as either AA or NHW
- BMI between 25 and 40 kg/m2
Exclusion Criteria
- diabetes
- unwillingness to follow prescribed diets
- recent weight change (>4 kg in past month)
- currently on a diet
- history of eating disorders or other psychiatric disorders
- digestive diseases
- difficulty chewing or swallowing
- reliance on others for meal preparation
- cardiovascular or pulmonary disease
- daily opioid pain medications
- use of medications known to alter metabolism or digestion (e.g., proton-pump inhibitors)
- use of anti-hypertensive medications that affect glucose tolerance
- use of tobacco
- participation in extreme exercise
- knee replacement
Data sourced from ClinicalTrials.gov (NCT04343716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.