Study Summary
This trial will test whether an amino acid supplement can help people who have had bariatric surgery to lose fat and maintain muscle mass.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 15 Secondary · Reporting Duration: 6 months after bariatric surgery
Month 6
Diet induced thermogenesis
Dietary Intake (Subjective)
Dietary intake (Objective)
Essential amino acids
Glucose
Insulin
Lean body mass
Liver fat mass
Muscle mass
Muscle protein fractional synthetic rate
Muscle protein synthetic rate
Percent muscle fat
Physical activity (Objective)
Physical activity (Subjective)
Resting energy expenditure
Subcutaneous fat mass
Total energy expenditure
Visceral fat mass
Weight
Whole body fat mass
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Commercially-available whey protein supplement - Beneprotein®
1 of 2
Proprietary Essential Amino Acid Protein Supplement
1 of 2
Active Control
Experimental Treatment
40 Total Participants · 2 Treatment Groups
Primary Treatment: Essential Amino Acid Protein Supplement · No Placebo Group · N/A
Proprietary Essential Amino Acid Protein Supplement
DietarySupplement
Experimental Group · 1 Intervention: Essential Amino Acid Protein Supplement · Intervention Types: DietarySupplementCommercially-available whey protein supplement - Beneprotein®
DietarySupplement
ActiveComparator Group · 1 Intervention: Beneprotein® · Intervention Types: DietarySupplementTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after bariatric surgery
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,142 Previous Clinical Trials
4,064,465 Total Patients Enrolled
90 Trials studying Weight Loss
17,560 Patients Enrolled for Weight Loss
The Amino Company, LLCUNKNOWN
Oregon Health and Science UniversityLead Sponsor
893 Previous Clinical Trials
6,829,334 Total Patients Enrolled
2 Trials studying Weight Loss
210 Patients Enrolled for Weight Loss
Nancy Puzziferri, MD MSCSPrincipal InvestigatorOregon Health and Science University
Eligibility Criteria
Age 18 - 60 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been evaluated by a bariatric surgeon and you have been determined to be a suitable candidate for bariatric surgery.
You have undergone a Roux-en-Y gastric bypass or sleeve gastrectomy.
You have no exclusion.
Who else is applying?
What state do they live in?
| Missouri | 25.0% |
| Texas | 25.0% |
| California | 25.0% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Oregon Health and Science University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 25.0% |
| Did not meet criteria | 75.0% |
References
- Paddon-Jones, Douglas, Melinda Sheffield-Moore, Randall J. Urban, Arthur P. Sanford, Asle Aarsland, Robert R. Wolfe, and Arny A. Ferrando. 2004. “Essential Amino Acid and Carbohydrate Supplementation Ameliorates Muscle Protein Loss in Humans During 28 Days Bedrest”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2003-032159.
- Paddon-Jones, Douglas, Melinda Sheffield-Moore, Christos S. Katsanos, Xiao-Jun Zhang, and Robert R. Wolfe. 2006. “Differential Stimulation of Muscle Protein Synthesis in Elderly Humans Following Isocaloric Ingestion of Amino Acids or Whey Protein”. Experimental Gerontology. Elsevier BV. doi:10.1016/j.exger.2005.10.006.
- Adams, Ted D., Antoinette M. Stroup, Richard E. Gress, Kenneth F. Adams, Eugenia E. Calle, Sherman C. Smith, R. Chad Halverson, Steven C. Simper, Paul N. Hopkins, and Steven C. Hunt. 2009. “Cancer Incidence and Mortality After Gastric Bypass Surgery”. Obesity. Wiley. doi:10.1038/oby.2008.610.
- Schollenberger, Asja E., Judith Karschin, Tobias Meile, Markus A. Küper, Alfred Königsrainer, and Stephan C. Bischoff. 2016. “Impact of Protein Supplementation After Bariatric Surgery: A Randomized Controlled Double-blind Pilot Study”. Nutrition. Elsevier BV. doi:10.1016/j.nut.2015.08.005.
- MacLean, Paul S., Audrey Bergouignan, Marc-Andre Cornier, and Matthew R. Jackman. 2011. “Biology's Response to Dieting: The Impetus for Weight Regain”. American Journal of Physiology-regulatory, Integrative and Comparative Physiology. American Physiological Society. doi:10.1152/ajpregu.00755.2010.
- Leibel, Rudolph L., Michael Rosenbaum, and Jules Hirsch. 1995. “Changes in Energy Expenditure Resulting from Altered Body Weight”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199503093321001.
- Goodpaster, Bret H, F Leland Thaete, and David E Kelley. 2000. “Thigh Adipose Tissue Distribution Is Associated with Insulin Resistance in Obesity and in Type 2 Diabetes Mellitus”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/71.4.885.
- King, Wendy C., Amanda S. Hinerman, Steven H. Belle, Abdus S. Wahed, and Anita P. Courcoulas. 2018. “Comparison of the Performance of Common Measures of Weight Regain After Bariatric Surgery for Association with Clinical Outcomes”. Jama. American Medical Association (AMA). doi:10.1001/jama.2018.14433.
- Felig, Philip, Oliver E. Owen, John Wahren, and George F. Cahill Jr.. 1969. “Amino Acid Metabolism During Prolonged Starvation”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci106017.
- Hector, Amy J., Chris McGlory, Felipe Damas, Nicole Mazara, Steven K. Baker, and Stuart M. Phillips. 2017. “Pronounced Energy Restriction with Elevated Protein Intake Results in No Change in Proteolysis and Reductions in Skeletal Muscle Protein Synthesis That Are Mitigated by Resistance Exercise”. The FASEB Journal. Wiley. doi:10.1096/fj.201700158rr.
- Courcoulas, Anita P., Wendy C. King, Steven H. Belle, Paul Berk, David R. Flum, Luis Garcia, William Gourash, et al.. 2018. “Seven-year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2017.5025.
- Sherwood, Louis M., Edith E. Parris, and George F. Cahill Jr.. 1970. “Starvation in Man”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm197003192821209.
- Børsheim, Elisabet, Quynh-Uyen T. Bui, Sandrine Tissier, Hisamine Kobayashi, Arny A. Ferrando, and Robert R. Wolfe. 2008. “Effect of Amino Acid Supplementation on Muscle Mass, Strength and Physical Function in Elderly”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2008.01.001.
- Kim, Il-Young, Sanghee Park, Ellen T. H. C. Smeets, Scott Schutzler, Gohar Azhar, Jeanne Y. Wei, Arny A. Ferrando, and Robert R. Wolfe. 2019. “Consumption of a Specially-formulated Mixture of Essential Amino Acids Promotes Gain in Whole-body Protein to a Greater Extent Than a Complete Meal Replacement in Older Women with Heart Failure”. Nutrients. MDPI AG. doi:10.3390/nu11061360.
- Goodpaster, Bret H., Remy Theriault, Simon C. Watkins, and David E. Kelley. 2000. “Intramuscular Lipid Content Is Increased in Obesity and Decreased by Weight Loss”. Metabolism. Elsevier BV. doi:10.1016/s0026-0495(00)80010-4.
- Lent, Michelle R., Yirui Hu, Peter N. Benotti, Anthony T. Petrick, G. Craig Wood, Christopher D. Still, and H. Lester Kirchner. 2018. “Demographic, Clinical, and Behavioral Determinants of 7-year Weight Change Trajectories in Roux-en-y Gastric Bypass Patients”. Surgery for Obesity and Related Diseases. Elsevier BV. doi:10.1016/j.soard.2018.07.023.
- Sjöström, Lars, Markku Peltonen, Peter Jacobson, C. David Sjöström, Kristjan Karason, Hans Wedel, Sofie Ahlin, et al.. 2012. “Bariatric Surgery and Long-term Cardiovascular Events”. Jama. American Medical Association (AMA). doi:10.1001/jama.2011.1914.
- Guillet, Christelle, Ingrid Delcourt, Melanie Rance, Christophe Giraudet, Stephane Walrand, Mario Bedu, Pascale Duche, and Yves Boirie. 2009. “Changes in Basal and Insulin and Amino Acid Response of Whole Body and Skeletal Muscle Proteins in Obese Men”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2008-2216.
- Bohé, Julien, J. F. Aili Low, Robert R. Wolfe, and Michael J. Rennie. 2001. “Rapid Report”. The Journal of Physiology. Wiley. doi:10.1111/j.1469-7793.2001.0575f.x.
- Dillon, Edgar L., Melinda Sheffield-Moore, Douglas Paddon-Jones, Charles Gilkison, Arthur P. Sanford, Shanon L. Casperson, Jie Jiang, David L. Chinkes, and Randall J. Urban. 2009. “Amino Acid Supplementation Increases Lean Body Mass, Basal Muscle Protein Synthesis, and Insulin-like Growth Factor-i Expression in Older Women”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2008-1564.
- Katsanos, Christos S., Hisamine Kobayashi, Melinda Sheffield-Moore, Asle Aarsland, and Robert R. Wolfe. 2006. “A High Proportion of Leucine Is Required for Optimal Stimulation of the Rate of Muscle Protein Synthesis by Essential Amino Acids in the Elderly”. American Journal of Physiology-endocrinology and Metabolism. American Physiological Society. doi:10.1152/ajpendo.00488.2005.
- Petersen, Kitt F, and Gerald I Shulman. 2002. “Pathogenesis of Skeletal Muscle Insulin Resistance in Type 2 Diabetes Mellitus”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/s0002-9149(02)02554-7.
- Liang, Chunzi, Benjamin J. Curry, Patricia L. Brown, and Michael B. Zemel. 2014. “Leucine Modulates Mitochondrial Biogenesis and SIRT1-AMPK Signaling in C2C12 Myotubes”. Journal of Nutrition and Metabolism. Hindawi Limited. doi:10.1155/2014/239750.
- Weijs, Peter J.M., and Robert R. Wolfe. 2016. “Exploration of the Protein Requirement During Weight Loss in Obese Older Adults”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2015.02.016.
- Maclean PS, Bergouignan A, Cornier MA, Jackman MR. Biology's response to dieting: the impetus for weight regain. Am J Physiol Regul Integr Comp Physiol. 2011 Sep;301(3):R581-600. doi: 10.1152/ajpregu.00755.2010. Epub 2011 Jun 15.
- Goodpaster BH, Thaete FL, Kelley DE. Thigh adipose tissue distribution is associated with insulin resistance in obesity and in type 2 diabetes mellitus. Am J Clin Nutr. 2000 Apr;71(4):885-92. doi: 10.1093/ajcn/71.4.885.
- Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.
- Borsheim E, Bui QU, Tissier S, Kobayashi H, Ferrando AA, Wolfe RR. Effect of amino acid supplementation on muscle mass, strength and physical function in elderly. Clin Nutr. 2008 Apr;27(2):189-95. doi: 10.1016/j.clnu.2008.01.001. Epub 2008 Mar 4.
- Leibel RL, Rosenbaum M, Hirsch J. Changes in energy expenditure resulting from altered body weight. N Engl J Med. 1995 Mar 9;332(10):621-8. doi: 10.1056/NEJM199503093321001. Erratum In: N Engl J Med 1995 Aug 10;333(6):399.
- Goodpaster BH, Theriault R, Watkins SC, Kelley DE. Intramuscular lipid content is increased in obesity and decreased by weight loss. Metabolism. 2000 Apr;49(4):467-72. doi: 10.1016/s0026-0495(00)80010-4.
- Felig P, Owen OE, Wahren J, Cahill GF Jr. Amino acid metabolism during prolonged starvation. J Clin Invest. 1969 Mar;48(3):584-94. doi: 10.1172/JCI106017.
- Petersen KF, Shulman GI. Pathogenesis of skeletal muscle insulin resistance in type 2 diabetes mellitus. Am J Cardiol. 2002 Sep 5;90(5A):11G-18G. doi: 10.1016/s0002-9149(02)02554-7.
- Cahill GF Jr. Starvation in man. N Engl J Med. 1970 Mar 19;282(12):668-75. doi: 10.1056/NEJM197003192821209. No abstract available.
- Bohe J, Low JF, Wolfe RR, Rennie MJ. Latency and duration of stimulation of human muscle protein synthesis during continuous infusion of amino acids. J Physiol. 2001 Apr 15;532(Pt 2):575-9. doi: 10.1111/j.1469-7793.2001.0575f.x.
- Schollenberger AE, Karschin J, Meile T, Kuper MA, Konigsrainer A, Bischoff SC. Impact of protein supplementation after bariatric surgery: A randomized controlled double-blind pilot study. Nutrition. 2016 Feb;32(2):186-92. doi: 10.1016/j.nut.2015.08.005. Epub 2015 Sep 1.
- Paddon-Jones D, Sheffield-Moore M, Urban RJ, Sanford AP, Aarsland A, Wolfe RR, Ferrando AA. Essential amino acid and carbohydrate supplementation ameliorates muscle protein loss in humans during 28 days bedrest. J Clin Endocrinol Metab. 2004 Sep;89(9):4351-8. doi: 10.1210/jc.2003-032159.
- Kim IY, Park S, Smeets ETHC, Schutzler S, Azhar G, Wei JY, Ferrando AA, Wolfe RR. Consumption of a Specially-Formulated Mixture of Essential Amino Acids Promotes Gain in Whole-Body Protein to a Greater Extent than a Complete Meal Replacement in Older Women with Heart Failure. Nutrients. 2019 Jun 17;11(6):1360. doi: 10.3390/nu11061360.
- Paddon-Jones D, Sheffield-Moore M, Katsanos CS, Zhang XJ, Wolfe RR. Differential stimulation of muscle protein synthesis in elderly humans following isocaloric ingestion of amino acids or whey protein. Exp Gerontol. 2006 Feb;41(2):215-9. doi: 10.1016/j.exger.2005.10.006. Epub 2005 Nov 23.
- Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. A high proportion of leucine is required for optimal stimulation of the rate of muscle protein synthesis by essential amino acids in the elderly. Am J Physiol Endocrinol Metab. 2006 Aug;291(2):E381-7. doi: 10.1152/ajpendo.00488.2005. Epub 2006 Feb 28.
- Nancy Puzziferri 2021. "Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751916.
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