Whole Food Plant-Based Smoothie for Knee Replacement

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether drinking a whole food plant-based smoothie daily for two weeks before knee replacement surgery can reduce inflammation, alter gut bacteria, and lower post-surgery pain and opioid use. Participants will either incorporate this smoothie into their diet or maintain their usual eating habits before surgery. Individuals with osteoarthritis scheduled for knee replacement surgery (not due to infection or trauma) might be suitable candidates, especially if they are willing to follow the smoothie plan. The main goal is to determine adherence to the diet and its impact on surgery recovery. As an unphased trial, this study provides a unique opportunity to understand how dietary changes might enhance surgical recovery.

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.

What prior data suggests that this dietary intervention is safe for patients undergoing knee replacement surgery?

Research has shown that whole food plant-based diets are generally safe and easy for most people to follow. Although specific safety data on whole food plant-based smoothies is lacking, studies on similar diets suggest they offer benefits without major risks. These diets, rich in fiber and nutrients, can help reduce inflammation and improve overall health.

Similar diet changes have not reported major negative effects. People on plant-based diets often experience positive health changes, such as reduced inflammation and improved digestion. Since the smoothie consists of whole foods, it is likely safe for most people, unless they have allergies to specific ingredients.

Overall, evidence suggests that a whole food plant-based smoothie is likely safe to consume, especially for short-term use, such as the two-week period before surgery in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a whole food plant-based fiber smoothie for knee replacement patients because it offers a natural, dietary approach that could improve recovery. Unlike standard treatments, which often focus on medications and physical therapy to manage symptoms and enhance healing, this smoothie leverages the benefits of plant-based nutrients and fiber to potentially reduce inflammation and promote healing from within. By incorporating a daily smoothie with ingredients guided by the American College of Lifestyle Medicine, this treatment provides an easy-to-follow, non-invasive regimen that might boost recovery times and overall joint health.

What evidence suggests that this smoothie might be an effective treatment for knee replacement?

Research has shown that a whole food plant-based diet can help reduce inflammation, which is important for healing after surgery. Studies have found that consuming more legumes, rich in fiber, is linked to a lower likelihood of needing knee replacement surgery. Although specific information about smoothies is limited, the overall benefits of plant-based diets suggest they might help lower inflammation. Reduced inflammation could lead to less pain and a decreased need for painkillers after surgery. In this trial, one group will receive a "Green Smoothie Guide" to prepare a daily smoothie for 14 days before their knee surgery, while another group will make no changes to their pre-operative diet. These potential benefits are the reason for testing the smoothie's effects before knee surgeries. ^{1 2 3 4 6}

Who Is on the Research Team?

Erica Tafuro, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-total-knee-arthroplasty-revision-4-2025-8dd38

Whole Food Plant-Based Smoothie for Knee Replacement This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that ...

2. ctv.veeva.com ctv.veeva.com/study/preoperative-whole-food-plant-based-fiber-smoothie-for-total-knee-arthroplasty-revision

Preoperative Whole Food Plant-Based Fiber Smoothie for ... This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34330847/

Food sources of dietary fibre and risk of total knee ... - PubMed Conclusion: Intake of legumes, but not total fibre, was associated with a reduced risk of TKR. Further research is needed to replicate our findings and to ...

4. facebook.com facebook.com/groups/134397200525317/posts/1506454863319537/

Can a whole food plant-based diet help with bone on ... Trying to find info/ articles on WFPB diet and if it helps with bone on bone knee pain. Specifically if it can help reverse need for bilateral ...

5. sciencedaily.com sciencedaily.com/releases/2025/09/250919085252.htm

Simple therapies outperform drugs for knee arthritis pain ... "Our analysis of nearly 10,000 patients reveals that simple, accessible therapies like knee bracing and water-based exercise outperform high- ...

6. prolianceorthopedicassociates.com prolianceorthopedicassociates.com/dr-barrett-blog/why-a-plant-based-diet-is-key-for-joint-replacement-and-your-overall-health

Plant-Based Diet is Key for Joint Replacement (and Overall ... The rate of obesity approaches 50% in joint replacement patients. The reasons are multifactorial, but the primary reason is diet ie what we consume on a daily ...