Testing of Micellar Casein, Blended Micellar Casein and Native Whey

NCT03021694 | Completed

• 1 other identifier: Aminoacidemia_Whey/Casein
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The importance of protein in nutrition is momentous to ones health. Dietary proteins are essentially nutritional because they contain amino acids, which the body uses to build its own proteins, as well as other molecules that are essential for life. Protein when consumed, travels through your digestive system and is absorbed. They then enter the blood for transport to bodily tissues, and therefore, can be detected by blood sampling. There are differing amounts of each amino acid found in different types of protein supplements. Certain amino acids (the essential amino acids) are helping in stimulating muscle growth and helping to maintain muscle mass and function. It is important to understand how quickly these amino acids can be detected in your blood as well as how they affect blood glucose (blood sugar) and insulin activity. Understanding the effects of protein type on changes in levels of blood amino acids, glucose and insulin will provide helpful insight for the suggestion of supplement use.

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (3)

• Postprandial blood amino acid concentrations

  repeated blood draws

  360 minutes

• Postprandial blood insulin concentrations

  repeated blood draws

  360 minutes

• Postprandial blood glucose concentrations

  repeated blood draws

  360 minutes

Study Arms (3)

Young Males Week 1

EXPERIMENTAL

Six separate 3 x 14 \[condition (micellar casein, micellar casein and native whey blend, and native whey) x time (-15min, 0 min, 15min, 30min, 45min, 60min, 90min, 150min, 180min, 210min, 240min, 270min, 300min, and 360min)\] repeated measures ANOVAs will be used to analyze blood concentrations of leucine, ∑branched chain amino acids, ∑essential amino acids, ∑amino acids, glucose, and insulin.

Dietary Supplement: Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men

Young Males Week 3

EXPERIMENTAL

Six separate 3 x 14 \[condition (micellar casein, micellar casein and native whey blend, and native whey) x time (-15min, 0 min, 15min, 30min, 45min, 60min, 90min, 150min, 180min, 210min, 240min, 270min, 300min, and 360min)\] repeated measures ANOVAs will be used to analyze blood concentrations of leucine, ∑branched chain amino acids, ∑essential amino acids, ∑amino acids, glucose, and insulin.

Dietary Supplement: Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men

Young Males Week 5

EXPERIMENTAL

Six separate 3 x 14 \[condition (micellar casein, micellar casein and native whey blend, and native whey) x time (-15min, 0 min, 15min, 30min, 45min, 60min, 90min, 150min, 180min, 210min, 240min, 270min, 300min, and 360min)\] repeated measures ANOVAs will be used to analyze blood concentrations of leucine, ∑branched chain amino acids, ∑essential amino acids, ∑amino acids, glucose, and insulin.

Dietary Supplement: Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men

Interventions

Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men DIETARY_SUPPLEMENT

Young Males Week 1; Young Males Week 3; Young Males Week 5

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• participants will be included in this study.
• Each participant will consume only one of the supplements in a double-blinded fashion during three separate visits and there will be approximately 1 week between each visit.
• In order to participate in this study, each participant must be male, between the ages of 18 and 30 years (inclusive) and cannot be a smoker or user of tobacco products.

You may not qualify if:

• Take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded. However, a washout period of 4 weeks will be suitable for participation.
• A history of neuromuscular problems or muscle and/or bone wasting diseases
• Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
• Use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (13)

• Rand WM, Pellett PL, Young VR. Meta-analysis of nitrogen balance studies for estimating protein requirements in healthy adults. Am J Clin Nutr. 2003 Jan;77(1):109-27. doi: 10.1093/ajcn/77.1.109.

  PMID: 12499330 BACKGROUND

• Coburn JW, Housh DJ, Housh TJ, Malek MH, Beck TW, Cramer JT, Johnson GO, Donlin PE. Effects of leucine and whey protein supplementation during eight weeks of unilateral resistance training. J Strength Cond Res. 2006 May;20(2):284-91. doi: 10.1519/R-17925.1.

  PMID: 16686554 BACKGROUND

• Bauer JM, Verlaan S, Bautmans I, Brandt K, Donini LM, Maggio M, McMurdo ME, Mets T, Seal C, Wijers SL, Ceda GP, De Vito G, Donders G, Drey M, Greig C, Holmback U, Narici M, McPhee J, Poggiogalle E, Power D, Scafoglieri A, Schultz R, Sieber CC, Cederholm T. Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2015 Sep 1;16(9):740-7. doi: 10.1016/j.jamda.2015.05.021. Epub 2015 Jul 10.

  PMID: 26170041 BACKGROUND

• Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24.

  PMID: 24814383 BACKGROUND

• Murphy CH, Oikawa SY, Phillips SM. Dietary Protein to Maintain Muscle Mass in Aging: A Case for Per-meal Protein Recommendations. J Frailty Aging. 2016;5(1):49-58. doi: 10.14283/jfa.2016.80.

  PMID: 26980369 BACKGROUND

• Biolo G, Fleming RY, Maggi SP, Nguyen TT, Herndon DN, Wolfe RR. Inverse regulation of protein turnover and amino acid transport in skeletal muscle of hypercatabolic patients. J Clin Endocrinol Metab. 2002 Jul;87(7):3378-84. doi: 10.1210/jcem.87.7.8699.

  PMID: 12107253 BACKGROUND

• Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.

  PMID: 19342610 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Blood Glucose

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 16, 2017
• Study Start: January 13, 2017
• Primary Completion: September 10, 2017
• Study Completion: January 15, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)