Dietary ModificationNCT03021694
Testing of Micellar Casein, Blended Micellar Casein and Native Whey
A study testing 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 in people with Dietary Modification, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2017to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 10 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.
Who cannot join
- The exclusion requirements for this study include the following conditions:
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: 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
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.
Read the detailed description
The importance of protein in nutrition is momentous to ones health. Dietary proteins are essentially nutritional because of their constituent amino acids, which the body uses to synthesize its own proteins, as well as nitrogen-containing molecules that are essential for life. The Recommended Dietary Allowance (RDA) for daily protein intake in healthy adults is 0.8 g/kgBW/day. Younger individuals who participate in recreational or competitive activities, however, often attempt to go beyond the RDA by using protein supplements to help increase performance. For example, it was demonstrated that protein supplementation in conjunction with an eight-week resistance-training program elicited greater improvements in muscle hypertrophy and strength when compared to carbohydrate supplementation in untrained men. There were 3.2 to 17.5% increases in muscle cross-sectional area of the quadriceps femoris musculature and 14.5 to 30.3% strength gains in the leg extensors. Furthermore, several expert groups have recently advocated that certain individuals, such as older persons, should increase their daily intake to 1.0 to 1.5 g/kgBW/day to support the preservation of muscle and function. Other conditions also place greater than normal demands on amino acids, such as hypercatabolic stressed states, like that experienced by burn patients who's muscle protein breakdown rate increases by impairment to inward transmembrane transport of circulating blood amino acids. It was also found that an experimental enriched protein "medical food" comprised of 27% of calories as total protein resulted in postprandial increases in MPS rates for 5 hours by ∼33% (0.073 ± 0.023%∙h-1 to 0.097 ± 0.033%∙h-1) in advanced cancer patients. Thus, continually reassessing new and innovative nutrient therapies is necessary for extending the findings of existing studies after technological advances, and for providing nutritional support-to-support health.
It is well known that dietary protein is a powerful transient stimulator of the muscle protein synthetic rate (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 suggested to be 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. The purpose of the present study is to test a novel blend of micellar casein combined with native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men.
- Conditions
- Dietary Modification
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult menDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood amino acid concentrations
repeated blood draws
Measured: 360 minutes
Postprandial blood insulin concentrations
repeated blood draws
Measured: 360 minutes
Postprandial blood glucose concentrations
repeated blood draws
Measured: 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start13 Jan 2017
- Primary completion10 Sep 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021694
- Sponsor's protocol ID
- Aminoacidemia_Whey/Casein
- Status last verified
- Feb 2018
- First submitted
- 11 Jan 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12499330Coburn 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.
PubMed 16686554Bauer 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.
PubMed 26170041Deutz 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.
PubMed 24814383Murphy 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.
PubMed 26980369Biolo 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.
PubMed 12107253Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.
PubMed 19342610Koopman 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.
PubMed 19474134Moore 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.
PubMed 19056590Katsanos 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.
PubMed 16507602Luiking 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.
PubMed 25790724Tipton 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.
PubMed 15570142Boirie 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.
PubMed 9405716
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03021694
- Acronym / sponsor ID
- Aminoacidemia_Whey/Casein
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The importance of protein in nutrition is momentous to ones health. Dietary proteins are essentially nutritional because of their constituent amino acids, which the body uses to synthesize its own proteins, as well as nitrogen-containing molecules that are essential for life. The Recommended Dietary Allowance (RDA) for daily protein intake in healthy adults is 0.8 g/kgBW/day. Younger individuals who participate in recreational or competitive activities, however, often attempt to go beyond the RDA by using protein supplements to help increase performance. For example, it was demonstrated that protein supplementation in conjunction with an eight-week resistance-training program elicited greater improvements in muscle hypertrophy and strength when compared to carbohydrate supplementation in untrained men. There were 3.2 to 17.5% increases in muscle cross-sectional area of the quadriceps femoris musculature and 14.5 to 30.3% strength gains in the leg extensors. Furthermore, several expert groups have recently advocated that certain individuals, such as older persons, should increase their daily intake to 1.0 to 1.5 g/kgBW/day to support the preservation of muscle and function. Other conditions also place greater than normal demands on amino acids, such as hypercatabolic stressed states, like that experienced by burn patients who's muscle protein breakdown rate increases by impairment to inward transmembrane transport of circulating blood amino acids. It was also found that an experimental enriched protein "medical food" comprised of 27% of calories as total protein resulted in postprandial increases in MPS rates for 5 hours by ∼33% (0.073 ± 0.023%∙h-1 to 0.097 ± 0.033%∙h-1) in advanced cancer patients. Thus, continually reassessing new and innovative nutrient therapies is necessary for extending the findings of existing studies after technological advances, and for providing nutritional support-to-support health.
It is well known that dietary protein is a powerful transient stimulator of the muscle protein synthetic rate (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 suggested to be 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. The purpose of the present study is to test a novel blend of micellar casein combined with native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young Males Week 1 | Experimental | 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 menSix 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. |
| Young Males Week 3 | Experimental | 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 menSix 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. |
| Young Males Week 5 | Experimental | 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 menSix 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 10 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.
Key exclusion criteria (5 listed)
- The exclusion requirements for this study include the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Postprandial blood amino acid concentrations
Time frame: 360 minutes
repeated blood draws
Postprandial blood insulin concentrations
Time frame: 360 minutes
repeated blood draws
Postprandial blood glucose concentrations
Time frame: 360 minutes
repeated blood draws
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Background: PubMed 12499330Rand 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.
- Background: PubMed 16686554Coburn 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.
- Background: PubMed 26170041Bauer 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.
- Background: PubMed 24814383Deutz 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.
- Background: PubMed 26980369Murphy 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.
- Background: PubMed 12107253Biolo 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.
- Background: PubMed 19342610Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.
- Background: PubMed 19474134Koopman 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.
- Background: PubMed 19056590Moore 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.
- Background: PubMed 16507602Katsanos 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.
- Background: PubMed 25790724Luiking 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.
- Background: PubMed 15570142Tipton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Dietary Modification, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial blood amino acid concentrations (time frame: 360 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021694, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.