The Impact of a Daily Whole Food Plant-based Smoothie Utilization 2 Weeks Prior to Revision Total Knee Replacement Surgery on Inflammation and Post-operative Pain.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility Measured in Terms of Compliance
研究概览
简要总结
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
详细描述
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:
- Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? [Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet]
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.
- Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.
- Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.
Participants will be randomly assigned to consume the whole food plant-based smoothie intervention daily for the two weeks leading up to surgery, or to have no preoperative diet intervention (control group).
The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Primary investigator will be blinded from which group participants are blinded from. Participants will be aware of what group they are in because they will be required to take the smoothie intervention before surgery. The RA will perform randomization and has to complete smoothie compliance calls.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for revision TKA at HSS with participating surgeons; not as a result of infection or trauma and all components (tibial and femoral) needing replacement
- •Age between 40 and 80
- •Diagnosed with osteoarthritis
- •Diagnosed with 2+ modifiable chronic lifestyle diseases: Type 2 DM, CVD (such as CAD, heart disease, stroke, HTN), stress, anxiety, depression, ADHD, metabolic syndrome, certain types of cancer (such as breast, colorectal, lung, prostate), Alzheimer's disease, vascular cognitive impairment, CKD, RA, asthma, chronic pain conditions (such as chronic back pain and osteoarthritis), fibromyalgia, migraines, COPD (Steiber 2011, Grant 2014)
- •ASA Class 1 ('normal' healthy patient) or 2 (patient with mild systemic disease and no functional limitations; the diseases the patient has are well controlled)
- •Ability to understand written and spoken English
- •Willing to complete entire pre-operative and post-operative work up in NYC, main campus site
- •Willing to follow a 2-week smoothie supplement, including willingness to purchase ingredients and have access to a blender for preparation
排除标准
- •Age >80 years or <40 years
- •Revision due to infection or trauma
- •ASA class 3 (patient with severe systemic disease that results in functional limitations) or 4 (patient with severe systemic disease that is a constant threat to life)
- •Not interested or unable to provide informed consent
- •Unstable weight (>5kg weight change in the past 3 months, documented in Epic) or currently on weight loss drugs such as GLP-1 agonists (Prasad et al., Cardiovasc Diabetol 2022; empagliflozin CRP studies.)
- •Active infection, flare-up of seasonal allergies, or physical trauma (all can alter CRP)
- •Medication changes the month leading up to surgery
- •Specifically medications altering inflammation: Statins (Ridker 2008), steroids (Boumpas et al., Ann Intern Med 1993; glucocorticoid cytokine modulation research.), DMARDS/biologics/immunosuppressants (Clinical rheumatology guidelines, biologic RCTs (e.g., TNF inhibitors, IL-6 inhibitors), Colchicine (Tardif et al., N Engl J Med 2019; colchicine cardiovascular inflammation studies.), hormone replacement therapies (Ridker et al., JAMA 1999; OCs and CRP meta-analyses.), new psychiatric medications (Miller & Raison, Nat Rev Immunol 2016; psychotropic-inflammation associations.)
- •BMI >40 kg/m2
- •Food intolerance/allergy/sensitivity to ingredients suggested for smoothies
- •History of IBD (and IBD medication)
- •History of bariatric surgery
- •History of cancer
- •History of thyroid disease
- •History of or current drug abuse
- •Pregnancy
- •Current smoker
- •Any patient with an electronic cardiac implant
研究组 & 干预措施
Group 1 No Smoothie
This group will make no changes to their pre-operative diet and will not consume the smoothie leading up to their TKA revision surgery.
Group 2 Smoothie
This group will receive the "Green Smoothie Guide" from the American College of Lifestyle Medicine which they will use to prepare a daily smoothie for the 14 days leading up to their total knee arthroplasty revision surgery. No other changes will be made to their pre-operative diet.
干预措施: Assigned Interventions (Dietary Supplement)
结局指标
主要结局
Feasibility Measured in Terms of Compliance
时间窗: Daily for 14 days pre-operative
Compliance is measured as number of days in the two-week intervention timeframe that patients reported having consumed the smoothie. The investigators will conduct fourteen daily phone calls to assess yes/no smoothie intake and ingredients used. Informed by nutrition compliance in the literature, the investigators will apply an 80% threshold for compliance rate which translates to roughly 11/14 days. The compliance range is 0%-100% or 0-14 days with 100% or 14 days indicating higher smoothie compliance and a more favorable outcome.
Feasibility Measured in Terms of Noted Barriers/Facilitators
时间窗: Day 0
Noted barriers/facilitators are open-ended questions in unstructured free text format. A feedback form will be sent to participants, and feedback and suggestions will be recorded by the investigators.
Feasibility Measured in Terms of Satisfaction with Diet
时间窗: Baseline and 6 weeks post-operative
The quantification of satisfaction with diet using the verified Diet Satisfaction Scale with 28 questions. Individual questions are scored on a scale of 1-5 with a higher score indicating higher diet satisfaction and a more favorable outcome. Scores from each question will be compiled into a total score for the questionnaire.
次要结局
- Inflammation and Pain Control: C-Reactive Protein(Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op)
- Inflammation and Pain Control: Interleukin 6(Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op)
- Inflammation and Pain Control: Microbiome Composition(Baseline, 4 Days Pre-op, 2 Days Pre-op)
- Inflammation and Pain Control- Numerical Rating Scales(Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op)
- Inflammation and Pain Control: Opioid Intake(Postoperatively; 0-24 hours, 24-48 hours, and 48-72 hours)
- Diet Quantification(Baseline, Day 0, and 6 weeks post-op.)
- BIA Measurements: Phase Angle(Baseline, Day 0, and 6 weeks post-op.)
- BIA Measurements: Fat-Free Mass (Index)(Baseline, Day 0, and 6 weeks post-op.)
- BIA Measurements: Extracellular Water(Baseline, Day 0, and 6 weeks post-op.)
- BIA Measurements: Extracellular Water, Total Body Water, and Ratio ECW/TBW(Baseline, Day 0, and 6 weeks post-op.)
- PROMIS-Global 10(Baseline, Day 0, 6 weeks post-op, and 6 months post-op.)
- Range of Motion(Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op)
- Frailty(Baseline)