Smoothie before surgery may ease knee pain
NCT ID NCT06896240
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study looks at whether drinking a daily whole food plant-based smoothie for two weeks before revision knee replacement surgery can lower inflammation and pain afterward. Twenty-four adults scheduled for surgery will either add the smoothie to their diet or make no changes. Researchers will measure compliance, inflammation markers, gut bacteria changes, and pain levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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HSS Main Hospital
RECRUITINGNew York, New York, 10021, United States
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