Fiber Smoothie Supplement for Total Knee Arthroplasty Revision
This study is looking at whether drinking a daily fiber-rich smoothie for two weeks before revision total knee arthroplasty (TKA) surgery can be helpful. They want to see if it's easy for people to stick to this diet plan, how satisfied they are with it, and if it can reduce inflammation or change gut bacteria. You might be able to join if you are between 40 and 80 years old, scheduled for revision TKA surgery (not due to infection or trauma), have osteoarthritis, and at least two chronic lifestyle diseases like Type 2 diabetes or heart disease. The study aims to enroll 24 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 24 participants. It compares a group who drinks a daily fiber smoothie before surgery to a control group who makes no dietary changes.
- What's involved
- You would integrate a daily whole food plant-based smoothie into your diet for two weeks prior to surgery. You would also provide daily feedback on compliance for 14 days pre-operative, and give feedback on satisfaction at baseline and 6 weeks post-operative.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for satisfaction with diet at 6 weeks post-operative. Inflammation markers would be measured at various points up to 6 weeks post-operative.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fiber Smoothie Supplement
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Erica Tafuro, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
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What this trial measures
- Feasibility Measured in Terms of ComplianceDaily for 14 days pre-operative
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.
- Feasibility Measured in Terms of Noted Barriers/FacilitatorsDay 0
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.
- Feasibility Measured in Terms of Satisfaction with DietBaseline and 6 weeks post-operative
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.