Whole Food Plant-Based Smoothie for Knee Replacement

Recruiting at 1 trial location

Overseen By Mia Zonies, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must not be taking: GLP-1 agonists, Statins

Disqualifiers: Age, Weight, Diet, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not start or stop any medications during the 2-week study period, as some medications can affect the study's measurements.

Is a whole food plant-based smoothie generally safe for humans?

There is no specific safety data on whole food plant-based smoothies, but studies on similar plant-based products and fibers suggest they are generally safe for human consumption. ^{1 2 3 4 5}

How does the Whole Food Plant-Based Fiber Smoothie treatment differ from other treatments for knee replacement recovery?

The Whole Food Plant-Based Fiber Smoothie is unique because it focuses on using whole, high-fiber plant foods, which are complex and contain a variety of beneficial compounds, unlike traditional treatments that may not emphasize dietary components. This approach may help improve overall diet composition and potentially aid in recovery by addressing issues like constipation, which can occur after surgery. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Erica Tafuro, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for patients scheduled for elective revision of total knee arthroplasty (TKA). Participants should be willing to consume a daily whole food plant-based smoothie for two weeks before surgery or continue their usual diet without changes. Specific eligibility criteria are not provided, but typically include being an adult and meeting health standards set by the study.

Inclusion Criteria

Ability to understand written and spoken English

Willing to complete entire pre-operative and post-operative work up in NYC, main campus site

I am scheduled for a knee replacement revision at HSS without infection or trauma reasons, replacing all parts.

Exclusion Criteria

Not interested or unable to provide informed consent

Food intolerance/allergy/sensitivity to ingredients suggested for smoothies

History of or current drug abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Dietary Intervention

Participants consume a daily whole food plant-based smoothie for 2 weeks prior to surgery

2 weeks

14 daily phone calls to assess compliance

Surgery and Immediate Postoperative Period

Participants undergo TKA revision surgery and are monitored for inflammation and pain control

Day 0 to Day 3 post-surgery

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including inflammation and pain control

6 weeks

6 weeks post-operative follow-up visit

Treatment Details

Interventions

• Whole Food Plant-Based Fiber Smoothie

Trial Overview The study tests if drinking a special whole food plant-based fiber smoothie every day for two weeks before TKA revision can reduce inflammation, change gut microbiome composition, lessen postoperative pain, and decrease opioid use compared to those who don't change their diet.

Participant Groups

Group I: Group 2 Smoothie Experimental Treatment 1 Intervention

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.

Group II: Group 1 No Smoothie Active Control 1 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.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Findings from Research

Current fiber intake levels are critically low, with over 90% of adults and children not meeting daily recommendations, which poses significant public health risks including heart disease, diabetes, and obesity.

High-fiber diets are associated with numerous health benefits, such as lowering LDL cholesterol, improving blood sugar control, aiding weight management, and enhancing gastrointestinal health, highlighting the urgent need for increased fiber consumption through education and dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Filling America's fiber intake gap: summary of a roundtable to probe realistic solutions with a focus on grain-based foods. Clemens, R., Kranz, S., Mobley, AR., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Filling America's fiber intake gap: summary of a roundtable to probe realistic solutions with a focus on grain-based foods. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Food sources of dietary fibre and risk of total knee replacement related to severe osteoarthritis, the Singapore Chinese Health Study. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

The safety of flavocoxid, a medical food, in the dietary management of knee osteoarthritis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

No long-term benefits of supplementation with arabinogalactan on serum lipids and glucose. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Implementing a bowel program: is a bowel program an effective way of preventing constipation and ileus following elective hip and knee arthroplasty surgery? [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Beyond dietary fiber. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Psyllium-enriched cereals lower blood total cholesterol and LDL cholesterol, but not HDL cholesterol, in hypercholesterolemic adults: results of a meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Plantago ovata (psyllium) husk and seeds on sterol metabolism: studies in normal and ileostomy subjects. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The effect of a fibre supplement compared to a healthy diet on body composition, lipids, glucose, insulin and other metabolic syndrome risk factors in overweight and obese individuals. [2017]