Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain

Description

Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. Non-Hispanic Black individuals (NHB) report greater disability and pain severity compared to Non-Hispanic Whites (NHW). These differences are reinforced through social and biological mechanisms, ultimately resulting in disparities in pain experience and associated quality of life. National efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological alternative. However, racial differences exist in metabolism that are rarely addressed in diet intervention studies. Therefore, a LCD may have greater pain-reducing effects in NHBs and provide an alternative treatment for pain. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables. Aim 1: To investigate the efficacy of the LCD to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: self-reported pain and evoked pain when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: QOL, mood, and self-reported improvement. Hypothesis 3: Both diets will result in improved pain disability, severity, catastrophizing and pain-related fear; the LCD will outperform the USDA diet. Objective 2: To explore racial differences in diet effects and baseline measures. Hypothesis 1: NHBs will show greater improvements in pain, QOL, and mood. Hypothesis 2: NHBs will report greater food insecurity and less proximity to grocery stores. Hypothesis 3: Diet quality will be negatively associated with baseline pain sensitivity. Objective 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures will predict: pain sensitivity and reductions in pain. NHBs will show greater inflammation at baseline than NHWs. Hypothesis 2: Change in physiological measures will be related to: change in pain, change in QOL, self-reported improvement and mood. NHWs will show greater reductions in inflammation and adiposity than NHBs.

Conditions

Knee Osteoarthritis

Study Overview

Study Details

Study overview

Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. Non-Hispanic Black individuals (NHB) report greater disability and pain severity compared to Non-Hispanic Whites (NHW). These differences are reinforced through social and biological mechanisms, ultimately resulting in disparities in pain experience and associated quality of life. National efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological alternative. However, racial differences exist in metabolism that are rarely addressed in diet intervention studies. Therefore, a LCD may have greater pain-reducing effects in NHBs and provide an alternative treatment for pain. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables. Aim 1: To investigate the efficacy of the LCD to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: self-reported pain and evoked pain when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: QOL, mood, and self-reported improvement. Hypothesis 3: Both diets will result in improved pain disability, severity, catastrophizing and pain-related fear; the LCD will outperform the USDA diet. Objective 2: To explore racial differences in diet effects and baseline measures. Hypothesis 1: NHBs will show greater improvements in pain, QOL, and mood. Hypothesis 2: NHBs will report greater food insecurity and less proximity to grocery stores. Hypothesis 3: Diet quality will be negatively associated with baseline pain sensitivity. Objective 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures will predict: pain sensitivity and reductions in pain. NHBs will show greater inflammation at baseline than NHWs. Hypothesis 2: Change in physiological measures will be related to: change in pain, change in QOL, self-reported improvement and mood. NHWs will show greater reductions in inflammation and adiposity than NHBs.

Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain

Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Robert E Sorge, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2027-06-30