Fiber Smoothie Supplement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHospital for Special Surgery, New York
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for revision TKA at HSS with participating surgeons; not as a result of infection or trauma and all components (tibial and femoral) needing replacement
Age between 40 and 85
Diagnosed with osteoarthritis
Diagnosed with 2+ modifiable chronic lifestyle diseases: Type 2 DM, CVD (such as CAD, heart disease, stroke, HTN), stress, anxiety, depression, ADHD, metabolic syndrome, certain types of cancer (such as breast, colorectal, lung, prostate), Alzheimer's disease, vascular cognitive impairment, CKD, RA, asthma, chronic pain conditions (such as chronic back pain and osteoarthritis), fibromyalgia, migraines, COPD (Steiber 2011, Grant 2014)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Assigned Interventions
Dietary supplementThe "Green Smoothie Guide" from the American College of Lifestyle Medicine contains guidelines for a 6-step smoothie to include whole and high fiber foods.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Group 1 No SmoothieNo intervention 0 interventions
Group B: Group 2 SmoothieExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility Measured in Terms of Compliance
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.
Time frame
Daily for 14 days pre-operative2
Feasibility Measured in Terms of Noted Barriers/Facilitators
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.
Time frame
Day 03
Feasibility Measured in Terms of Satisfaction with Diet
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.
Time frame
Baseline and 6 weeks post-operativeSecondary outcomes
1
Inflammation and Pain Control: C-Reactive Protein
Inflammation and pain control are quantified by biological markers of inflammation such as C-reactive protein found in the blood. C-reactive protein is produced in the liver, and its levels rise in response to inflammation. A normal range of C-reactive protein is less than 0.3mg/dL and is a more favorable outcome than an elevated level of C-reactive protein.
Time frame
Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op2
Inflammation and Pain Control: Interleukin 6
Inflammation and pain control are quantified by biological markers of inflammation such as the pro-inflammatory cytokine, interleukin 6, found in the blood. An elevated amount of Interleukin 6, above 15pg/mL, is indicative of increased inflammatory response in the body and is less favorable outcome.
Time frame
Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op3
Inflammation and Pain Control: Microbiome Composition
Inflammation and pain control are quantified firstly by biological markers of inflammation such as microbiome composition. Participants will complete three self-administered stool sample collections and ship their samples to Mount Sinai Laboratory. Mount Sinai will conduct raw 16S rRNA sequencing to show alpha and beta bacteria diversity. Higher diversity 4 days pre-op and 2 days pre-op relative to baseline is indicative of a more successful intervention and a more favorable outcome.
Time frame
Baseline, 4 Days Pre-op, 2 Days Pre-op4
Inflammation and Pain Control- Numerical Rating Scales
Inflammation and pain control are quantified firstly by markers of acute pain/analgesia which are measured by Numerical Rating Scales (NRS) of pain. Participants will be asked questions about their knee pain on a scale of 0-10 where higher scores are indicative of increased pain and a less favorable outcome.
Time frame
Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-opSponsors and contacts
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Source ClinicalTrials.gov