Supplementation of a Leucine-enriched Protein Blend

NCT03796897 | Completed Early Phase 1

• 1 other identifier: 5706
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that dietary protein transiently stimulates muscle protein synthesis (MPS) whereby changes in MPS in response to feeding may be regulated by specific downstream target proteins of mammalian target of rapamycin signaling, such as S6K1, rpS6, and eIF2B. A meal deficient in protein, however, does not increase the rate of MPS because a rise in the bioavailability of amino acids does not occur. In addition, the source of dietary proteins has been shown to impact postprandial blood levels of amino acids. The concept that certain types of proteins are "fast acting" or "slow acting" has been shown to affect the postprandial profile of amino acids appearing in the systemic circulation. Native whey and micellar casein are both dairy proteins that contain a similar amount of essential (EAA), but blood EAA levels increase faster and to a higher level after the consumption of whey protein. Differences in gastric emptying, digestion and absorption kinetics between micellar casein and native whey are the underlying factors. Nonetheless, micellar casein protein has been shown to protract MPS in humans. Despite the significant amount of information gained with respect to both of these protein sources, the effects of combinatorial formulations on the postprandial profile of amino acids appearing in the blood is less well known.

Conditions

Dietary Modification; Diet Habit

Outcome Measures

Primary Outcomes (1)

• Integrated Muscle Protein Synthetic Rate

  oral deuterium consumption: Isotope protocol (See ref., PMID 23821570)

  10 days

Study Arms (2)

Leucine-enriched protein + exercise

EXPERIMENTAL

whey protein- hydrolyzed whey protein-micellar casein blend (50:43:7 whey:hydrolyzed-whey:casein), vitamin D, and free leucine

Dietary Supplement: Leucine-enriched protein

Habitual diet + exercise

SHAM COMPARATOR

habitual diet only

Behavioral: Habitual diet only

Interventions

Leucine-enriched protein DIETARY_SUPPLEMENT

Supplement contains 16g of protein given twice per exercise session (4 total exercise sessions)

Leucine-enriched protein + exercise

Habitual diet only BEHAVIORAL

Habitual diet only (no supplementation) for 4 exercise sessions

Habitual diet + exercise

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18-29 years (inclusive)
• Be able to maintain a habitual diet, physical activity patterns, and body mass throughout the trial
• Be in general good health
• Be able to participate in resistance training and aerobic training
• Understand the study procedures and sign this form providing informed consent to participate in the study
• Be able to consume a protein bar in the allotted time frame of 10 minutes

You may not qualify if:

• Smoker
• Excessive alcohol consumption (more than 21 units of alcohol / week; 1 unit of alcohol is approximately 25 mL of spirits (40% alcohol), 250 mL of beer (4% alcohol) or 75 mL of wine (13% alcohol))
• Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which you are being treated that might put you at risk for this study
• Have a known or suspected allergy to local anesthetics such as lidocaine
• Have a dairy protein allergy
• Participation in another nutrition or exercise research study
• Do not understand English or have a condition the PI believes would interfere with a participants' ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put someone at undue risk
• Use of medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
• Consuming a vegan diet
• Use of an investigational drug product or nutraceutical within the last 30 days
• Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (9)

• Koopman R, Crombach N, Gijsen AP, Walrand S, Fauquant J, Kies AK, Lemosquet S, Saris WH, Boirie Y, van Loon LJ. Ingestion of a protein hydrolysate is accompanied by an accelerated in vivo digestion and absorption rate when compared with its intact protein. Am J Clin Nutr. 2009 Jul;90(1):106-15. doi: 10.3945/ajcn.2009.27474. Epub 2009 May 27.

  PMID: 19474134 RESULT

• Koopman R, Walrand S, Beelen M, Gijsen AP, Kies AK, Boirie Y, Saris WH, van Loon LJ. Dietary protein digestion and absorption rates and the subsequent postprandial muscle protein synthetic response do not differ between young and elderly men. J Nutr. 2009 Sep;139(9):1707-13. doi: 10.3945/jn.109.109173. Epub 2009 Jul 22.

  PMID: 19625697 RESULT

• Moore DR, Robinson MJ, Fry JL, Tang JE, Glover EI, Wilkinson SB, Prior T, Tarnopolsky MA, Phillips SM. Ingested protein dose response of muscle and albumin protein synthesis after resistance exercise in young men. Am J Clin Nutr. 2009 Jan;89(1):161-8. doi: 10.3945/ajcn.2008.26401. Epub 2008 Dec 3.

  PMID: 19056590 RESULT

• 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.

  PMID: 16507602 RESULT

• Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5.

  PMID: 25790724 RESULT

• Tipton KD, Elliott TA, Cree MG, Wolf SE, Sanford AP, Wolfe RR. Ingestion of casein and whey proteins result in muscle anabolism after resistance exercise. Med Sci Sports Exerc. 2004 Dec;36(12):2073-81. doi: 10.1249/01.mss.0000147582.99810.c5.

  PMID: 15570142 RESULT

• Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrere B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5. doi: 10.1073/pnas.94.26.14930.

  PMID: 9405716 RESULT

• MacDonald AJ, Small AC, Greig CA, Husi H, Ross JA, Stephens NA, Fearon KC, Preston T. A novel oral tracer procedure for measurement of habitual myofibrillar protein synthesis. Rapid Commun Mass Spectrom. 2013 Aug 15;27(15):1769-77. doi: 10.1002/rcm.6622.

  PMID: 23821570 RESULT

• Lim C, Traylor DA, McGlory C, Joanisse S, McKendry J, Grewal T, Mcleod JC, Prior T, Nunes EA, Lees M, Phillips SM. Increased protein intake derived from leucine-enriched protein enhances the integrated myofibrillar protein synthetic response to short-term resistance training in untrained men and women: a 4-day randomized controlled trial. Appl Physiol Nutr Metab. 2022 Nov 1;47(11):1104-1114. doi: 10.1139/apnm-2022-0164. Epub 2022 Sep 20.

  PMID: 36126327 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Interventions

P3H1 protein, human

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 8, 2019
• Study Start: June 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

CA (1)