Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- WOMAC Pain Change
研究概览
简要总结
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.
详细描述
A telephone screening interview will be used to assess each participant's OA status and assessment of the reported duration of knee OA, current and past treatments, comorbid conditions, current medication use, dietary conditions and other exclusion criteria. Eligible, participants will be invited to the testing facilities in Campbell Hall for informed consent and baseline measures. Following this visit, participants will record daily food consumption for one week as well as daily pain ratings. After one week, participants will visit the Clinical Research Unit for fasted blood draw and additional testing. Immediately following this session, participants will be asked to select one week of meals and snacks from a menu of commercially-available meals. Study personnel will record the choices and order the meals to be delivered to the participants to initiate the intervention. During the 6-week intervention, participants will be contacted by study personnel weekly to place food orders and be instructed to record any beverages consumed during the week. Every three weeks, participants will return for testing. At the end of 6 weeks, blood will be taken prior to testing/debriefing.
Participants. The investigators will recruit 20 adult women (65-75) with knee OA with equal representation across racial groups (10 AA, 10 NHW). Peak prevalence rates for OA are at the 65-75 years of age, so the investigators feel confident that there will be no trouble recruiting this population. Participants will be recruited using existing databases, community flyers and community outreach. The feasibility trial used prescribed diets and had an attrition rate of 0% in the LCD group. Here, provision of all of the food for the intervention is expected to have lower rates of attrition.
Inclusion criteria will include:
- 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 will be the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
White women
White women aged 65-75 with knee OA
干预措施: Low-carbohydrate diet (Behavioral)
Black women
Black women aged 65-75 with knee OA
干预措施: Low-carbohydrate diet (Behavioral)
结局指标
主要结局
WOMAC Pain Change
时间窗: Baseline (week 0), immediately after the intervention (6 weeks)
The Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score is a 0-20 score with higher scores reflecting more severe pain. Questions 1-5 are summed to provide a WOMAC pain score. Change scores will be calculated. The week 6 WOMAC pain subscale score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.
BPI Pain Change
时间窗: Baseline (week 0), immediately after the intervention (6 weeks)
The Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.
次要结局
- WOMAC Physical Function(Baseline (week 0), immediately after the intervention (6 weeks))
- BPI Pain Interference Change(Baseline (week 0), immediately after the intervention (6 weeks))
- TS Pain Intensity Change(Baseline (week 0), immediately after the intervention (6 weeks))
- RCS Pain Intensity Change(Baseline (week 0), immediately after the intervention (6 weeks))
- PHQ-9 Depression Change(Baseline (week 0), immediately after the intervention (6 weeks))
研究者
Robert Sorge
Associate Professor
University of Alabama at Birmingham