Status:
NOT_YET_RECRUITING
Fiber Smoothie Supplement
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Total Knee Arthroplasty Revision
Inflammatory Markers
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06896240
Start Date
January 1 2026
End Date
January 1 2028
Last Update
December 26 2025
Active Locations (1)
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1
HSS Main Hospital
New York, New York, United States, 10021