Fiber Smoothie Supplement

NCT06896240 | Not Yet Recruiting

• 1 other identifier: 2024-2396
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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. 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. 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. 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. 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. 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.

Conditions

Total Knee Arthroplasty Revision; Inflammatory Markers; Gut Microbiota

Keywords

TKA Revision; Inflammation; Diet; Gut Microbiome

Outcome Measures

Primary Outcomes (3)

• Feasibility Measured in Terms of Compliance

  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.

  Daily for 14 days pre-operative

• Feasibility Measured in Terms of Noted Barriers/Facilitators

  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.

  Day 0

• Feasibility Measured in Terms of Satisfaction with Diet

  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.

  Baseline and 6 weeks post-operative

Secondary Outcomes (13)

• 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

Study Arms (2)

Group 1 No Smoothie

NO INTERVENTION

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

EXPERIMENTAL

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.

Dietary Supplement: Assigned Interventions

Interventions

Assigned Interventions DIETARY_SUPPLEMENT

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.

Group 2 Smoothie

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

HSS Main Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Tafuro, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Zonies, BS

CONTACT

646-714-6849; zoniesm@hss.edu

Pa Thor, PhD

CONTACT

646-797-8535; thorp@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized control trial of two groups, intervention vs. control.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)