Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-10
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Shake and instructions
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.
Nutritional Shake
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.
Nutrition Instructions Only
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
Nutritional Instructions Only
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
Interventions
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Nutritional Shake
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 Only
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
70 Years
ALL
Yes
Sponsors
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Hitchcock Foundation
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Stacie.G.Deiner
LeRoy Garth Professor and Vice Chair for Research, Department of Anesthesiology
Principal Investigators
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Stacie G Deiner, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Central Contacts
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References
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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.
Lawton 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.
Katz 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.
Nasreddine 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.
Mendoza 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.
Pavlin 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.
Ljungqvist 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.
Berger 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.
Norman 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.
Valletta 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.
Roberts 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.
Wischmeyer 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.
Williams 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.
Williams 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.
Fried 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.
Becher RD, Vander Wyk B, Leo-Summers L, Desai MM, Gill TM. The Incidence and Cumulative Risk of Major Surgery in Older Persons in the United States. Ann Surg. 2023 Jan 1;277(1):87-92. doi: 10.1097/SLA.0000000000005077. Epub 2021 Jul 14.
Deiner S, Baxter MG, Mincer JS, Sano M, Hall J, Mohammed I, O'Bryant S, Zetterberg H, Blennow K, Eckenhoff R. Human plasma biomarker responses to inhalational general anaesthesia without surgery. Br J Anaesth. 2020 Sep;125(3):282-290. doi: 10.1016/j.bja.2020.04.085. Epub 2020 Jun 11.
Evered L, Silbert B, Scott DA, Zetterberg H, Blennow K. Association of Changes in Plasma Neurofilament Light and Tau Levels With Anesthesia and Surgery: Results From the CAPACITY and ARCADIAN Studies. JAMA Neurol. 2018 May 1;75(5):542-547. doi: 10.1001/jamaneurol.2017.4913.
Other Identifiers
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STUDY02002743
Identifier Type: -
Identifier Source: org_study_id
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