Fiber Smoothie Supplement

Официальное название

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.

Обзор

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: 1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \[Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet\] 2. 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. 3. 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. 4. 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. 5. 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.

Подробное описание

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:

1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \[Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet\] 2. 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. 3. 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. 4. 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. 5. 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.

Вмешательства

• Пищевая добавка Assigned Interventions
  The "Green Smoothie Guide" from the American College of Lifestyle Medicine contains guidelines for a 6-step smoothie to include whole and high fiber foods.

Первичные конечные точки

• Feasibility Measured in Terms of Compliance [Срок оценки: Daily for 14 days pre-operative]
• Feasibility Measured in Terms of Noted Barriers/Facilitators [Срок оценки: Day 0]
• Feasibility Measured in Terms of Satisfaction with Diet [Срок оценки: Baseline and 6 weeks post-operative]

Вторичные конечные точки (12)

• Inflammation and Pain Control: C-Reactive Protein [Срок оценки: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op]
• Inflammation and Pain Control: Interleukin 6 [Срок оценки: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op]
• Inflammation and Pain Control: Microbiome Composition [Срок оценки: Baseline, 4 Days Pre-op, 2 Days Pre-op]
• Inflammation and Pain Control- Numerical Rating Scales [Срок оценки: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op]
• Inflammation and Pain Control: Opioid Intake [Срок оценки: Postoperatively; 0-24 hours, 24-48 hours, and 48-72 hours]
• Diet Quantification [Срок оценки: Baseline, Day 0, and 6 weeks post-op.]
• BIA Measurements: Phase Angle [Срок оценки: Baseline, Day 0, and 6 weeks post-op.]
• BIA Measurements: Fat-Free Mass (Index) [Срок оценки: Baseline, Day 0, and 6 weeks post-op.]
• BIA Measurements: Extracellular Water [Срок оценки: Baseline, Day 0, and 6 weeks post-op.]
• BIA Measurements: Extracellular Water, Total Body Water, and Ratio ECW/TBW [Срок оценки: Baseline, Day 0, and 6 weeks post-op.]
• PROMIS-Global 10 [Срок оценки: Baseline, Day 0, 6 weeks post-op, and 6 months post-op.]
• Range of Motion [Срок оценки: Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op]

Критерии участия

Inclusion:

• 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

Exclusion:

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• HSS Main Hospital — New York

Идентификаторы

NCT: NCT06896240 · 2024-2396

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗