Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

ACL Injury Clinical Trial

Official title:

The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03614351
• Other study ID #: IRB00046590
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.

Description:

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Participants with a complete ACL tear and received a hamstring autograft ACL repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with WFBH at D1 outpatient rehabilitation

• Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)

Exclusion Criteria:

• Subjects must not have other ligamentous involvement, or complications during the surgical procedure.

• They must not have had a concurrent meniscal repair (debridement is acceptable).

• They must not have post-operative limitations that interfere with rehabilitation.

• Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.

• Females who are pregnant will not be permitted in the study.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Dietary Supplement:
• Protein (PROT)
Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.

Other:
• Control (CONT)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

References & Publications (28)

Alisson-Silva F, Kawanishi K, Varki A. Human risk of diseases associated with red meat intake: Analysis of current theories and proposed role for metabolic incorporation of a non-human sialic acid. Mol Aspects Med. 2016 Oct;51:16-30. doi: 10.1016/j.mam.2016.07.002. Epub 2016 Jul 12. Review. — View Citation

Antonio J, Ellerbroek A, Silver T, Vargas L, Tamayo A, Buehn R, Peacock CA. A High Protein Diet Has No Harmful Effects: A One-Year Crossover Study in Resistance-Trained Males. J Nutr Metab. 2016;2016:9104792. Epub 2016 Oct 11. — View Citation

Askanazi J, Carpentier YA, Jeevanandam M, Michelsen CB, Elwyn DH, Kinney JM. Energy expenditure, nitrogen balance, and norepinephrine excretion after injury. Surgery. 1981 Apr;89(4):478-84. — View Citation

Burke LE, Conroy MB, Sereika SM, Elci OU, Styn MA, Acharya SD, Sevick MA, Ewing LJ, Glanz K. The effect of electronic self-monitoring on weight loss and dietary intake: a randomized behavioral weight loss trial. Obesity (Silver Spring). 2011 Feb;19(2):338-44. doi: 10.1038/oby.2010.208. Epub 2010 Sep 16. — View Citation

Campbell WW, Johnson CA, McCabe GP, Carnell NS. Dietary protein requirements of younger and older adults. Am J Clin Nutr. 2008 Nov;88(5):1322-9. — View Citation

Coughlin SS, Whitehead M, Sheats JQ, Mastromonico J, Hardy D, Smith SA. Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review. Jacobs J Food Nutr. 2015;2(3):021. — View Citation

Crane CW, Picou D, Smith R, Waterlow JC. Protein turnover in patients before and after elective orthopaedic operations. Br J Surg. 1977 Feb;64(2):129-33. — View Citation

Cresci GA. Nutrition Support for the Critically Ill Patient: A Guide to Practice. Boca Raton, FL. CRC Press, 2005.

Crickmer M, Dunne CP, O'Regan A, Coffey JC, Dunne SS. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials. World J Gastrointest Surg. 2016 Jul 27;8(7):521-32. doi: 10.4240/wjgs.v8.i7.521. — View Citation

Daly RM, O'Connell SL, Mundell NL, Grimes CA, Dunstan DW, Nowson CA. Protein-enriched diet, with the use of lean red meat, combined with progressive resistance training enhances lean tissue mass and muscle strength and reduces circulating IL-6 concentrations in elderly women: a cluster randomized controlled trial. Am J Clin Nutr. 2014 Apr;99(4):899-910. doi: 10.3945/ajcn.113.064154. Epub 2014 Jan 29. — View Citation

Fabre M, Hausswirth C, Tiollier E, Molle O, Louis J, Durguerian A, Neveux N, Bigard X. Effects of Postexercise Protein Intake on Muscle Mass and Strength During Resistance Training: Is There an Optimal Ratio Between Fast and Slow Proteins? Int J Sport Nutr Exerc Metab. 2017 Oct;27(5):448-457. doi: 10.1123/ijsnem.2016-0333. Epub 2017 Apr 19. — View Citation

Fulgoni VL 3rd. Current protein intake in America: analysis of the National Health and Nutrition Examination Survey, 2003-2004. Am J Clin Nutr. 2008 May;87(5):1554S-1557S. — View Citation

Harrison GG, Galal OM, Ibrahim N, Khorshid A, Stormer A, Leslie J, Saleh NT. Underreporting of food intake by dietary recall is not universal: a comparison of data from egyptian and american women. J Nutr. 2000 Aug;130(8):2049-54. — View Citation

Haynes RB, McDonald HP, Garg AX. Helping patients follow prescribed treatment: clinical applications. JAMA. 2002 Dec 11;288(22):2880-3. — View Citation

Herzog MM, Marshall SW, Lund JL, Pate V, Mack CD, Spang JT. Incidence of Anterior Cruciate Ligament Reconstruction Among Adolescent Females in the United States, 2002 Through 2014. JAMA Pediatr. 2017 Aug 1;171(8):808-810. doi: 10.1001/jamapediatrics.2017.0740. — View Citation

Hurt RT, McClave SA, Martindale RG, Ochoa Gautier JB, Coss-Bu JA, Dickerson RN, Heyland DK, Hoffer LJ, Moore FA, Morris CR, Paddon-Jones D, Patel JJ, Phillips SM, Rugeles SJ, Sarav Md M, Weijs PJ, Wernerman J, Hamilton-Reeves J, McClain CJ, Taylor B. Summary Points and Consensus Recommendations From the International Protein Summit. Nutr Clin Pract. 2017 Apr;32(1_suppl):142S-151S. doi: 10.1177/0884533617693610. — View Citation

Iizaka S, Kaitani T, Nakagami G, Sugama J, Sanada H. Clinical validity of the estimated energy requirement and the average protein requirement for nutritional status change and wound healing in older patients with pressure ulcers: A multicenter prospective cohort study. Geriatr Gerontol Int. 2015 Nov;15(11):1201-9. doi: 10.1111/ggi.12420. Epub 2014 Dec 11. — View Citation

Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010 Sep-Oct;51(3-4):214-21. doi: 10.1016/j.ypmed.2010.06.004. Epub 2010 Jun 15. — View Citation

Mather RC 3rd, Koenig L, Kocher MS, Dall TM, Gallo P, Scott DJ, Bach BR Jr, Spindler KP; MOON Knee Group. Societal and economic impact of anterior cruciate ligament tears. J Bone Joint Surg Am. 2013 Oct 2;95(19):1751-9. doi: 10.2106/JBJS.L.01705. — View Citation

Millward DJ, Jackson AA. Protein/energy ratios of current diets in developed and developing countries compared with a safe protein/energy ratio: implications for recommended protein and amino acid intakes. Public Health Nutr. 2004 May;7(3):387-405. Review. — View Citation

Naclerio F, Larumbe-Zabala E, Ashrafi N, Seijo M, Nielsen B, Allgrove J, Earnest CP. Effects of protein-carbohydrate supplementation on immunity and resistance training outcomes: a double-blind, randomized, controlled clinical trial. Eur J Appl Physiol. 2017 Feb;117(2):267-277. doi: 10.1007/s00421-016-3520-x. Epub 2016 Dec 27. — View Citation

Naclerio F, Larumbe-Zabala E. Effects of Whey Protein Alone or as Part of a Multi-ingredient Formulation on Strength, Fat-Free Mass, or Lean Body Mass in Resistance-Trained Individuals: A Meta-analysis. Sports Med. 2016 Jan;46(1):125-137. doi: 10.1007/s40279-015-0403-y. — View Citation

Novotny JA, Rumpler WV, Riddick H, Hebert JR, Rhodes D, Judd JT, Baer DJ, McDowell M, Briefel R. Personality characteristics as predictors of underreporting of energy intake on 24-hour dietary recall interviews. J Am Diet Assoc. 2003 Sep;103(9):1146-51. — View Citation

Ohura T, Nakajo T, Okada S, Omura K, Adachi K. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial). Wound Repair Regen. 2011 May-Jun;19(3):330-6. doi: 10.1111/j.1524-475X.2011.00691.x. — View Citation

Pasiakos SM, McLellan TM, Lieberman HR. The effects of protein supplements on muscle mass, strength, and aerobic and anaerobic power in healthy adults: a systematic review. Sports Med. 2015 Jan;45(1):111-31. doi: 10.1007/s40279-014-0242-2. Review. — View Citation

Phillips SM. Current Concepts and Unresolved Questions in Dietary Protein Requirements and Supplements in Adults. Front Nutr. 2017 May 8;4:13. doi: 10.3389/fnut.2017.00013. eCollection 2017. Review. — View Citation

Schoenfeld BJ, Aragon A, Wilborn C, Urbina SL, Hayward SE, Krieger J. Pre- versus post-exercise protein intake has similar effects on muscular adaptations. PeerJ. 2017 Jan 3;5:e2825. doi: 10.7717/peerj.2825. eCollection 2017. Erratum in: PeerJ. 2017 Aug 1;5:. — View Citation

Trommelen J, van Loon LJ. Pre-Sleep Protein Ingestion to Improve the Skeletal Muscle Adaptive Response to Exercise Training. Nutrients. 2016 Nov 28;8(12). pii: E763. Review. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of individuals that complied with treatment/intervention	Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured.	up to 6 months
Primary	Percentage of frequency individuals successfully used the protein tracking app	Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance.	up to 6 months
Primary	Percentage of physical therapy visits attended by individuals	Compliance in physical therapy will be recorded.	up to 6 months
Primary	Percentage counseling sessions attended by individuals	Compliance in attending nutritional counseling sessions will be recorded.	up to 6 months
Secondary	Single Leg Hop Test	Functional healing time based on single leg hop test. The distance the participant hopped on one leg will be recorded and measured in centimeters. This will be done three times and an average will be given.	baseline and up to 6 month
Secondary	Six Meter Timed Hop Test	Functional healing time based six meter timed hop test. The time it took the participant to hop six meters on foot will be measured and recorded.	baseline and up to 6 month
Secondary	Change in strength in leg flexion and extension	Strength in leg flexion and extension, as measured by Biodex machine	baseline and up to 6 month
Secondary	Change in muscle hypertrophy	depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.	baseline and up to 6 month