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Fiber Smoothie Supplement

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 19 words
  2. Notable Primary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 11 of 13 entries
    • Study description expanded, about 5 words
  3. Notable Recruitment opened
    • Start date changed from estimate of May 2026 to Apr 28, 2026
    • Site details revised
    v7
  4. Notable Start date: Feb 2026 to May 2026v6
  5. Minor Start date: Jan 2026 to Feb 2026v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Primary completion date: Sep 1, 2026 to Jan 1, 2027v4 Show 4 more changesShow less
    • Study completion date: Sep 1, 2026 to Jan 1, 2028
    • Start date: Jul 2026 to Jan 2026
    • Eligibility criteria expanded, about 82 words
    • Study title shortened, about 8 words
  2. Notable Primary completion date: Sep 1, 2025 to Sep 1, 2026
    • Start date: Jul 1, 2025 to Jul 2026
    • Study completion date: Mar 1, 2026 to Sep 1, 2026
    v3
  3. Notable Start date: May 1, 2025 to Jul 1, 2025v2 Show 4 more changesShow less
    • Primary completion date: Feb 1, 2026 to Sep 1, 2025
    • Study completion date: Apr 1, 2026 to Mar 1, 2026
    • Secondary endpoints: 12 to 13
    • Eligibility criteria expanded, about 4 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06896240
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)
Total Knee Arthroplasty Revision, Inflammatory Markers, Gut Microbiota
Related terms Inflammation
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov