Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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:
Participants will be randomly assigned to consume the whole food plant-based smoothie intervention daily for the two weeks leading up to surgery, or to have no preoperative diet intervention (control group).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 No Smoothie | No 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. | |
| Group 2 Smoothie | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assigned Interventions | Dietary Supplement | The "Green Smoothie Guide" from the American College of Lifestyle Medicine contains guidelines for a 6-step smoothie to include whole and high fiber foods. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 14 days pre-operative |
| 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. | Day 0 |
| 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. | Baseline and 6 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia Zonies, BS | Contact | 646-714-6849 | zoniesm@hss.edu | |
| Pa Thor, PhD | Contact | 646-797-8535 | thorp@hss.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erica Tafuro, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HSS Main Hospital | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
A randomized control trial of two groups, intervention vs. control.
Not provided
Not provided
Primary investigator will be blinded from which group participants are blinded from. Participants will be aware of what group they are in because they will be required to take the smoothie intervention before surgery. The RA will perform randomization and has to complete smoothie compliance calls.
| Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op |
| 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. | Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op |
| 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. | Baseline, 4 Days Pre-op, 2 Days Pre-op |
| 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. | Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op |
| Inflammation and Pain Control: Opioid Intake | Inflammation and pain control are quantified by markers of acute pain/analgesia such as opioid intake. Opioid intake will be recorded from participants' medical charts while they are under care at HSS Main Hospital. Opioid intake will be measured in morphine milligram equivalents (MME) with a lower opioid intake being more favorable. | Postoperatively; 0-24 hours, 24-48 hours, and 48-72 hours |
| Diet Quantification | Diet will be quantified using Diet ID Inc.'s online software, a validated tool, which measures diet quality, caloric intake, and nutrient intake. After participants go through the Diet ID survey, the Diet ID platform will calculate a "Nutrition Score" which will be the recorded value of nutrition. The scores will be reported on a scale of 1-10 with higher scores indicating "better" nutrition and a more favorable outcome. | Baseline, Day 0, and 6 weeks post-op. |
| BIA Measurements: Phase Angle | Bioelectrical Impedance Analysis (BIA) produces a measurement of phase angle (PhA) which measures the water distribution among intracellular and extracellular space. Phase angle is measured in degrees with 6.5-7.5 degrees being described as a healthy range and lower degrees being less favorable. | Baseline, Day 0, and 6 weeks post-op. |
| BIA Measurements: Fat-Free Mass (Index) | Bioelectrical Impedance Analysis (BIA) produces a measurement of fat-free mass (FFM) which is a measurement of the total body weight excluding fat. BIA testing produces a fat-free mass weight in kg which is divided by the total kg of the participant to produce a percentage of fat-free mass. For men, a healthy range for a fat-free mass percentage is ~78%-87%, and for women, a healthy range is ~67%-75%. The fat-free mass index measurement can also be calculated using the measurement of fat-free mass relative to height. | Baseline, Day 0, and 6 weeks post-op. |
| BIA Measurements: Extracellular Water | Bioelectrical Impedance Analysis (BIA) can produce measurements of extracellular water (ECW) which is the water outside of the cells. | Baseline, Day 0, and 6 weeks post-op. |
| BIA Measurements: Extracellular Water, Total Body Water, and Ratio ECW/TBW | Bioelectrical Impedance Analysis (BIA) can produce measurements of Extracellular Water (ECW)--the fluid outside of the cells--and Total Body Water (TBW). Then, a ratio of extracellular water to total body water (ECW/TBW) can be calculated with a normal range for this ratio being 0.360-0.390. A higher value for this ratio is indicative of a less favorable outcome. | Baseline, Day 0, and 6 weeks post-op. |
| PROMIS-Global 10 | The PROMIS-Global 10 is a validated 10-item questionnaire to evaluate health in relation to quality of life. Questions are rated on a scale of 1-5 with a higher score being indicative of higher health and a more favorable outcome. Scores for all questions will be added up to calculate a total score. | Baseline, Day 0, 6 weeks post-op, and 6 months post-op. |
| Range of Motion | Angle of knee movement in degrees as recorded during all standard of care visits. Measurement points include: the internist physician during pre-surgical screening, the surgeon on Day 0, physical therapy on Days 1-3, the surgeon during the 6-week post-operative follow-up visit. | Baseline, Day 0, Day 1, Day 2, Day 3, 6 weeks post-op |
| Frailty | The 5-Item frailty index is a standardized, comorbidity-based risk stratification tool used to predict adverse events. | Baseline |