Postoperative CareNCT07109505
Nutrition to Support Postoperative Recovery
A study testing Nutritional Shake and Nutritional Instructions Only in people with Postoperative Care and Postoperative Complications, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care, Postoperative Complications, Cognition
- What is being tested?
- Nutritional Shake and Nutritional Instructions Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- patients >=70 years old having major orthopedic or abdominal surgery, defined as a procedure with a planned inpatient stay of at least one night.
Who cannot join
- emergency surgery, diagnosis of dementia or major psychiatric diagnosis such as schizophrenia, Parkinson's disease, inability to consent for themselves, unwilling or unable to complete all study requirements and measurements, any known food allergy, dislike of shake flavor(s), unwilling or unable to tolerate caffeine in shake, unable to take oral nutrition, BMI >45, diagnosis of an eating disorder, insulin dependent diabetes.
- MRI procedure eligibility will be assessed using the DHMC Department of Radiology's standard MRI Safety Checklist, which screens for potential contraindications to MRI scanning such as metal in the body, possible exposure to metal in the eyes, pregnancy, and claustrophobia. Any individual with a contraindication to MRI scanning will not be eligible to participate in the optional MRI component.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Stacie G Deiner, MD, 631-974-2444, Stacie.G.Deiner@hitchcock.org
Emma K Toes, BA, 603-650-0381, Emma.K.Toes@hitchcock.org
About this study
Official title: Comparison of Clinical and Patient Centered Outcomes: Postoperative Multi-nutrient Meal Plus Enhanced Recovery vs. Enhanced Recovery Alone
Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.
Read the detailed description
We will recruit a cohort of community dwelling patients, age 70 years and older for elective major abdominal and orthopedic surgery. Demographics, medical history, medications will be obtained from the electronic health record and confirmed with the patient. Patients randomized to the nutrition shake arm will receive a provided daily nutritional shake (starting when they leave the hospital and for 1-month after hospital discharge). The shake consists of a comprehensive panel of essential nutrients to support maintenance of muscle, metabolic and brain health.
- Conditions
- Postoperative Care, Postoperative Complications, Cognition, Nutritional Assessment, Nutritional Intervention
- Being tested
- Nutritional Shake, Nutritional Instructions Only
- Keywords
- Nutrition, Postoperative, Cognition
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional ShakeDietary supplement
The shake mixes will be dry shelf -stable powders prepared with ingredients readily available in the US food supply and contain a minimum of 990 mg total cocoa flavanols, with a profile to support general nutritional health including 10 g protein. Accordingly, each shake contains approximately 95 mg of caffeine, equivalent to a medium-sized cup of coffee. Based on prior studies of cognition, additional composition specifications are: 1600 mg DHA and up to 400 mg EPA and 550 mg choline; >250 mg epicatechin and epigallocatechin (plant polyphenols); multivitamin/mineral fortification to ensure 50-100% of all essential micronutrients except calcium (to prevent competitive absorption with other divalent cations). Participants will be given a supply of pre-portioned daily servings upon discharge from the hospital, for 30 days after surgery.
Nutritional Instructions OnlyOther
The control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation
| Study group | Role | What they receive |
|---|---|---|
| Shake and instructions | Experimental | For the intervention arm, an unblinded study team member will deliver and review the Nutrition After Surgery and postoperative supplementation instructions with the participant.
Additionally, an unblinded study team member will give each participant a 30-day supply of single-servings. They will be instructed to consume 1 packet per day for 30 days, reconstituted per instructions (see instructions file), after discharge from the hospital. The unblinded researchers will work with the coordinator team to provide participants with a plan for supplementation (normal or underweight participants) or meal replacement (overweight or obese patients). Participants will be instructed to keep track of their shake consumption on a daily basis. Shake consumption logs will be collected via REDCap surveys sent to participants and reviewed by the unblinded coordinators/investigators for adverse events and compliance. Receives: Dietary Supplement: Nutritional Shake |
| Nutrition Instructions Only | Other | The control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation Receives: Other: Nutritional Instructions Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1a: Postoperative change in disability scores
This aim will compare postoperative change in disability scores, as measured by World Health Organization Assessment Schedule 2.0 (WHODAS 2.0), from baseline to 1 month and baseline to 3 months. Results will be scored on a 5-point Likert scale and summed to a total score ranging 0 to 100, where 0 indicates no disability and 100 indicates full disability. The outcome will compare patients receiving a 30-day supply of daily nutritional shake and general healthy nutrition recommendations versus those only receiving general healthy nutrition recommendations without a provided shake
Measured: 90 days
Aim 1b: Postoperative change in cognitive function
This aim will compare postoperative change in cognitive function, as measured by The Montreal Cognitive Assessment (T-MoCA), from baseline to 1 month and baseline to 3 months. Scores will range from 0 to 30 points, with higher scores indicating greater cognitive function. The outcome will compare patients receiving a 30-day supply of a daily nutritional shake and general healthy nutritional recommendations versus those receiving only healthy nutritional recommendations without a provided shake.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Dec 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization assignment will consist of two groups: Shake and instructions or instructions only.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hitchcock Foundation
- Responsible party
- Principal investigator, Stacie.G.Deiner, Dartmouth-Hitchcock Medical Center
- Investigators
- Stacie G Deiner, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109505
- Sponsor's protocol ID
- STUDY02002743
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The consent does not ask participants to share their data outside the study
Publications
Katz MJ, Wang C, Nester CO, Derby CA, Zimmerman ME, Lipton RB, Sliwinski MJ, Rabin LA. T-MoCA: A valid phone screen for cognitive impairment in diverse community samples. Alzheimers Dement (Amst). 2021 Feb 5;13(1):e12144. doi: 10.1002/dad2.12144. eCollection 2021.
PubMed 33598528Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
PubMed 6418786Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Mendoza TR, Chen C, Brugger A, Hubbard R, Snabes M, Palmer SN, Zhang Q, Cleeland CS. The utility and validity of the modified brief pain inventory in a multiple-dose postoperative analgesic trial. Clin J Pain. 2004 Sep-Oct;20(5):357-62. doi: 10.1097/00002508-200409000-00011.
PubMed 15322443Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.
PubMed 15599135Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Berger MM, Amrein K, Barazzoni R, Bindels L, Breton I, Calder PC, Cappa S, Cuerda C, D'Amelio P, de Man A, Delzenne NM, Forbes A, Genton L, Gombart AF, Joly F, Laviano A, Matthys C, Phyo PP, Ravasco P, Serlie MJ, Shenkin A, Stoffel NU, Talwar D, van Zanten ARH. The science of micronutrients in clinical practice - Report on the ESPEN symposium. Clin Nutr. 2024 Jan;43(1):268-283. doi: 10.1016/j.clnu.2023.12.006. Epub 2023 Dec 9.
PubMed 38104489Norman K, Hass U, Pirlich M. Malnutrition in Older Adults-Recent Advances and Remaining Challenges. Nutrients. 2021 Aug 12;13(8):2764. doi: 10.3390/nu13082764.
PubMed 34444924Valletta M, Vetrano DL, Calderon-Larranaga A, Kalpouzos G, Canevelli M, Marengoni A, Laukka EJ, Grande G. Association of mild and complex multimorbidity with structural brain changes in older adults: A population-based study. Alzheimers Dement. 2024 Mar;20(3):1958-1965. doi: 10.1002/alz.13614. Epub 2024 Jan 3.
PubMed 38170758Roberts SB, Franceschini MA, Silver RE, Taylor SF, de Sa AB, Co R, Sonco A, Krauss A, Taetzsch A, Webb P, Das SK, Chen CY, Rogers BL, Saltzman E, Lin PY, Schlossman N, Pruzensky W, Bale C, Chui KKH, Muentener P. Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial. BMJ. 2020 Jul 22;370:m2397. doi: 10.1136/bmj.m2397.
PubMed 32699176Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
PubMed 29369092Williams DGA, Villalta E, Aronson S, Murray S, Blitz J, Kosmos V, Wischmeyer PE; Duke Perioperative Enhancement Team (POET). Tutorial: Development and Implementation of a Multidisciplinary Preoperative Nutrition Optimization Clinic. JPEN J Parenter Enteral Nutr. 2020 Sep;44(7):1185-1196. doi: 10.1002/jpen.1824. Epub 2020 Mar 31.
PubMed 32232882Williams JD, Wischmeyer PE. Assessment of perioperative nutrition practices and attitudes-A national survey of colorectal and GI surgical oncology programs. Am J Surg. 2017 Jun;213(6):1010-1018. doi: 10.1016/j.amjsurg.2016.10.008. Epub 2016 Nov 17.
PubMed 27889271Fried TR, Tinetti ME, Iannone L, O'Leary JR, Towle V, Van Ness PH. Health outcome prioritization as a tool for decision making among older persons with multiple chronic conditions. Arch Intern Med. 2011 Nov 14;171(20):1854-6. doi: 10.1001/archinternmed.2011.424. Epub 2011 Sep 26. No abstract available.
PubMed 21949032
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Patient Centered Outcomes: Postoperative Multi-nutrient Meal Plus Enhanced Recovery vs. Enhanced Recovery Alone
- ClinicalTrials.gov ID
- NCT07109505
- Acronym / sponsor ID
- STUDY02002743
- Conditions
- Postoperative Care, Postoperative Complications, Cognition, Nutritional Assessment, Nutritional Intervention
- Keywords
- Nutrition, Postoperative, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Hitchcock Foundation
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.
Detailed description
We will recruit a cohort of community dwelling patients, age 70 years and older for elective major abdominal and orthopedic surgery. Demographics, medical history, medications will be obtained from the electronic health record and confirmed with the patient. Patients randomized to the nutrition shake arm will receive a provided daily nutritional shake (starting when they leave the hospital and for 1-month after hospital discharge). The shake consists of a comprehensive panel of essential nutrients to support maintenance of muscle, metabolic and brain health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The randomization assignment will consist of two groups: Shake and instructions or instructions only.
| Arm | Type | Receives |
|---|---|---|
| Shake and instructions | Experimental | Dietary Supplement: Nutritional ShakeFor the intervention arm, an unblinded study team member will deliver and review the Nutrition After Surgery and postoperative supplementation instructions with the participant. Additionally, an unblinded study team member will give each participant a 30-day supply of single-servings. They will be instructed to consume 1 packet per day for 30 days, reconstituted per instructions (see instructions file), after discharge from the hospital. The unblinded researchers will work with the coordinator team to provide participants with a plan for supplementation (normal or underweight participants) or meal replacement (overweight or obese patients). Participants will be instructed to keep track of their shake consumption on a daily basis. Shake consumption logs will be collected via REDCap surveys sent to participants and reviewed by the unblinded coordinators/investigators for adverse events and compliance. |
| Nutrition Instructions Only | Other | Other: Nutritional Instructions OnlyThe control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients >=70 years old having major orthopedic or abdominal surgery, defined as a procedure with a planned inpatient stay of at least one night.
Key exclusion criteria (2 listed)
- emergency surgery, diagnosis of dementia or major psychiatric diagnosis such as schizophrenia, Parkinson's disease, inability to consent for themselves, unwilling or unable to complete all study requirements and measurements, any known food allergy, dislike of shake flavor(s), unwilling or unable to tolerate caffeine in shake, unable to take oral nutrition, BMI >45, diagnosis of an eating disorder, insulin dependent diabetes.
- MRI procedure eligibility will be assessed using the DHMC Department of Radiology's standard MRI Safety Checklist, which screens for potential contraindications to MRI scanning such as metal in the body, possible exposure to metal in the eyes, pregnancy, and claustrophobia. Any individual with a contraindication to MRI scanning will not be eligible to participate in the optional MRI component.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional ShakeThe shake mixes will be dry shelf -stable powders prepared with ingredients readily available in the US food supply and contain a minimum of 990 mg total cocoa flavanols, with a profile to support general nutritional health including 10 g protein. Accordingly, each shake contains approximately 95 mg of caffeine, equivalent to a medium-sized cup of coffee. Based on prior studies of cognition, additional composition specifications are: 1600 mg DHA and up to 400 mg EPA and 550 mg choline; >250 mg epicatechin and epigallocatechin (plant polyphenols); multivitamin/mineral fortification to ensure 50-100% of all essential micronutrients except calcium (to prevent competitive absorption with other divalent cations). Participants will be given a supply of pre-portioned daily servings upon discharge from the hospital, for 30 days after surgery. | Dietary supplement | Shake and instructions |
| Nutritional Instructions OnlyThe control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation | Other | Nutrition Instructions Only |
Primary outcome
Aim 1a: Postoperative change in disability scores
Time frame: 90 days
This aim will compare postoperative change in disability scores, as measured by World Health Organization Assessment Schedule 2.0 (WHODAS 2.0), from baseline to 1 month and baseline to 3 months. Results will be scored on a 5-point Likert scale and summed to a total score ranging 0 to 100, where 0 indicates no disability and 100 indicates full disability. The outcome will compare patients receiving a 30-day supply of daily nutritional shake and general healthy nutrition recommendations versus those only receiving general healthy nutrition recommendations without a provided shake
Aim 1b: Postoperative change in cognitive function
Time frame: 90 days
This aim will compare postoperative change in cognitive function, as measured by The Montreal Cognitive Assessment (T-MoCA), from baseline to 1 month and baseline to 3 months. Scores will range from 0 to 30 points, with higher scores indicating greater cognitive function. The outcome will compare patients receiving a 30-day supply of a daily nutritional shake and general healthy nutritional recommendations versus those receiving only healthy nutritional recommendations without a provided shake.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 33598528Katz MJ, Wang C, Nester CO, Derby CA, Zimmerman ME, Lipton RB, Sliwinski MJ, Rabin LA. T-MoCA: A valid phone screen for cognitive impairment in diverse community samples. Alzheimers Dement (Amst). 2021 Feb 5;13(1):e12144. doi: 10.1002/dad2.12144. eCollection 2021.
- Background: PubMed 5349366Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
- Background: PubMed 6418786Katz S. Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living. J Am Geriatr Soc. 1983 Dec;31(12):721-7. doi: 10.1111/j.1532-5415.1983.tb03391.x.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 15322443Mendoza TR, Chen C, Brugger A, Hubbard R, Snabes M, Palmer SN, Zhang Q, Cleeland CS. The utility and validity of the modified brief pain inventory in a multiple-dose postoperative analgesic trial. Clin J Pain. 2004 Sep-Oct;20(5):357-62. doi: 10.1097/00002508-200409000-00011.
- Background: PubMed 15599135Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 38104489Berger MM, Amrein K, Barazzoni R, Bindels L, Breton I, Calder PC, Cappa S, Cuerda C, D'Amelio P, de Man A, Delzenne NM, Forbes A, Genton L, Gombart AF, Joly F, Laviano A, Matthys C, Phyo PP, Ravasco P, Serlie MJ, Shenkin A, Stoffel NU, Talwar D, van Zanten ARH. The science of micronutrients in clinical practice - Report on the ESPEN symposium. Clin Nutr. 2024 Jan;43(1):268-283. doi: 10.1016/j.clnu.2023.12.006. Epub 2023 Dec 9.
- Background: PubMed 34444924Norman K, Hass U, Pirlich M. Malnutrition in Older Adults-Recent Advances and Remaining Challenges. Nutrients. 2021 Aug 12;13(8):2764. doi: 10.3390/nu13082764.
- Background: PubMed 38170758Valletta M, Vetrano DL, Calderon-Larranaga A, Kalpouzos G, Canevelli M, Marengoni A, Laukka EJ, Grande G. Association of mild and complex multimorbidity with structural brain changes in older adults: A population-based study. Alzheimers Dement. 2024 Mar;20(3):1958-1965. doi: 10.1002/alz.13614. Epub 2024 Jan 3.
- Background: PubMed 32699176Roberts SB, Franceschini MA, Silver RE, Taylor SF, de Sa AB, Co R, Sonco A, Krauss A, Taetzsch A, Webb P, Das SK, Chen CY, Rogers BL, Saltzman E, Lin PY, Schlossman N, Pruzensky W, Bale C, Chui KKH, Muentener P. Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial. BMJ. 2020 Jul 22;370:m2397. doi: 10.1136/bmj.m2397.
- Background: PubMed 29369092Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
- Individual participant dataSharing planned: No. The consent does not ask participants to share their data outside the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacie G Deiner, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Shake and Nutritional Instructions Only in people with Postoperative Care and Postoperative Complications, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacie G Deiner, MD ((603) 650-5922, Stacie.G.Deiner@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1a: Postoperative change in disability scores (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07109505, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.