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NCT06896240 · ClinicalTrials.gov registry record · NA

Fiber Smoothie Supplement

A NA study, sponsored by Hospital for Special Surgery, New York.

Not yet
Registry status
NA
Development phase
24
Enrollment target

NCT06896240: Clinical Trial NA study, sponsored by Hospital for Special Surgery, New York.

NCT06896240 is a NA study that has not yet begun recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06896240, a NA study, has not yet begun recruiting, sponsored by Hospital for Special Surgery, New York.

NOT YET RECRUITING
Registry status
NA
Development phase
24 participants
Enrollment target

Study 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. 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 pr

Primary Outcome

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 com

Interventions

  • DIETARY_SUPPLEMENT Assigned Interventions

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2026-05
Est. Completion 2028-01-01
Phase NA

What is known before NCT06896240 opens enrollment

NCT06896240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Assigned Interventions is the first listed.

NCT06896240 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06896240 about?

NCT06896240 is a clinical study titled "Fiber Smoothie Supplement". 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 m...

What is the current status of trial NCT06896240?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2026-05. Estimated completion is 2028-01-01.

What interventions are being tested in trial NCT06896240?

The interventions under investigation include: Assigned Interventions (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT06896240?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06896240's enrollment target sits among peer trials

24 1736th of 2000 higher than 246 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06896240, the US trial registry maintained by the National Library of Medicine. NCT06896240 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.