Fiber Smoothie Supplement

NCT ID
NCT06896240
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Hospital for Special Surgery, New York
Conditions
Gut Microbiota, Inflammatory Markers, Total Knee Arthroplasty Revision

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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.

Enrollment: 24 participants (Estimated).

What is being studied

  • Dietary supplement: Assigned Interventions

Who may be eligible

Ages
40 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 85 * 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) or 3 (patient with severe systemic disease that results in functional limitations) * Ability to understand written and spoken English * Willing to complete entire pre-operative and post-operative work up in NYC, main campus site and/or HSS Ambulatory Care Center * Willing to follow a 2-week smoothie supplement, including willingness to purchase ingredients and have access to a blender for preparation Exclusion: * Age \>85 years or \<40 years * Revision due to infection or trauma * ASA class 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) * 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • HSS Main Hospital — New York, New York, 10021, United States — Recruiting

Study details

Start date
April 28, 2026
Primary completion date
January 1, 2027
Completion date
January 1, 2028
First posted
March 26, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06896240
Registry last updated
September 28, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06896240 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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