HealthyNCT03712761
Supplementation of a Leucine-Enriched Dairy Protein Blend
An observational study of Healthy, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Enriched Protein®
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2018to 1 Jun 2020
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: Healthy Older Adults
Who may be able to join
- 8 participants will be included in this study. Each participant will consume the supplement only once in a randomized fashion during one of 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 or female, 65 years or older (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: Supplementation of a Leucine-Enriched Dairy Protein Blend: Effects on Plasma Amino Acids in Older Adults
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 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 determine post-ingestion aminoacidemia, glycemia, and insulinemia from a specially formulated dairy protein blend.
Read the detailed description
Experimental approach:
8 participants will be included in this study. Each participant will consume the supplement only once in a randomized fashion during three separate visits and there will be approximately 1 week between each visit.
Standardized meal:
Participants will be provided a standardized diet one day prior to experimentation. When performing research involving human metabolism it is important that the participants be tested in a weight-stable state. Therefore, the investigators will estimate the participants resting energy expenditure using a widely reference prediction formula, known as the Harris-Benedict equation. This formula takes into account gender, body mass, height, age, and self-reported activity level. Once resting energy expenditure is calculated the investigators will provide each participant with a pre-packaged standardized diet for the day prior to the experiment that is designed to ensure a sufficient energy balance.
Dual Energy X-Ray Absorptiometry (DXA) Scans:
DXA scans will be used to determine the participants body composition. The DXA procedures use a small amount of radiation to determine how much fat, bone, and lean mass the participants have in their body. The procedure takes approximately seven minutes and involves the participants lying still on an open bed while the sensor passes over the participants body.
Arterialized blood sampling:
All blood sampling will be achieved through an intravenous indwelling cannula. This method provides the least trauma to the participant when repeated blood sampling is required and is convenient for the investigators. In theory, repeated needle sticks may stress the participant thereby increasing sympathetic nervous system activity, thus causing changes in metabolism. Additionally, another potential drawback from venous blood sampling is the influence by regional tissue specific metabolism, thereby making it difficult to interpret whole-body metabolism on the basis of metabolites measured in venous blood. Therefore, arterial blood sampling is deemed the ideal method for metabolic studies. Arterial cannulation, however, may be unethical for research purposes due to increased risk of complications, such as damage to the arterial wall, thrombosis, and clot formation, all of which may cause death. Arterializing the blood being sampled can be achieved through heating either the superficial antecubital vein or dorsal hand vein with a heating blanket or specialized heat box. By doing so, blood flow increases as a result of vasodilatation of vessels in the arms skeletal musculature, as well as arteriovenous anastomoses in skin. Due to the increased blood flow and negligible muscle mass at the hand and elbow, results in venous blood being similar in composition to an arterial sample. This method is a widely used surrogate for safe direct arterial blood sampling. Once arterialized blood samples are obtained they will be preserved and used in analyses. The investigators will utilize heating blankets (Theratherm Large Digital Moist Heat Pad [14" x 27"]) to arterialize the blood samples and an infrared thermometer (Nubee, NUB8380) to determine the skin temperature (45-68∘C) prior to drawing the participant's blood.
Per-protocol conditions will include:
Consumption of a standardized meal the evening prior to each trial and consistent exercise/activity 2d before each trial There will be ~1wk between trials (washout periods) Blood samples will be analyzed for plasma amino acids, glucose, and insulin.
Experimental Interventions (randomized order):
- Participants will consume a Low Protein Containing Breakfast (10% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine) and 2 hours later the participants will consume 17g of a leucine enriched whey protein- hydrolyzed whey protein-micellar casein blend (50:43:7 whey:hydrolyzed-whey:casein) containing 600 IU Vitamin D and 3.5g leucine
- Participants will consume a High Protein Containing Breakfast (25% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine)
- Participants will consume a Low Protein Containing Breakfast (10% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine)
Proteins were provided by Covance Laboratories, Inc. owned by Eurofins.
The whey protein and micellar casein are milk proteins derived from cow's milk. The participants will consume the 17g of protein contained in a semi-solid bar equal to ∼40g, which is the size of a typical sports recovery bar.
Sample size and data analyses:
The sample size was determined by a statistical power analysis (G*Power 3.1 software, version 3.1.9, 2014) that revealed a large effect size. This study was powered on the basis of previous studies. Thus, a total of 8 (n = 8/group) participants will be used in analyses. See Below:
Analysis: A priori: Compute required sample size ANOVA: Repeated measures, within-between interaction Input Effect size f = 0.5 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 3 Number of measurements = 14 Corr. Among rep. measures = 0.5 Nonsphericity correction ε = 1 Output Noncentrality parameter ƛ = 63 Critical F = 1.6380186 Numerator df = 26 Denominator df = 78 Total sample = 9 Actual power = 0.997
- Conditions
- Healthy
- Being tested
- Enriched Protein®
- Keywords
- Dietary Protein Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Protein®Dietary supplement
This product contains high quality bovine milk proteins enriched with additional leucine.
| Study group | Role | What they receive |
|---|---|---|
| Supplementation with Enriched Protein® | Participants will consume a low protein containing breakfast and 2 hours later will consume the enriched protein supplement Receives: Dietary Supplement: Enriched Protein® | |
| Low protein breakfast | No supplementation | |
| High protein breakfast | No supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Easy-fast amino acid sample testing kit for gas chromatography mass spectrometry
plasma amino acid concentrations
Measured: 375 minutes
Secondary outcomes (15)
Hexokinase/G-6-PDH methodology
plasma glucose concentrations
Measured: 375 minutes
Chemiluminescent Microparticle Immunoassay
plasma insulin concentrations
Measured: 375 minutes
Visual Analog Scale Questionnaires for food sensory perception desire to eat
Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for hunger
Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for fullness
Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for thirst
Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for how much food could be eaten
Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for liking or disliking of food
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for visual appeal
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for smell
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for taste
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for aftertaste
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for pleasantness
Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score
Measured: Average score across 2 measurements
Height in meters
Stadiometer
Measured: One measurement at baseline
Weight in kilograms
Physician scale
Measured: One measurement at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start28 Mar 2018
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
- Investigators
- Stuart M Phillips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712761
- Sponsor's protocol ID
- 2502
- Status last verified
- Jun 2024
- First submitted
- 16 Oct 2018
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19474134Koopman 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.
PubMed 19625697Moore 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 9405716Douglas CC, Lawrence JC, Bush NC, Oster RA, Gower BA, Darnell BE. Ability of the Harris Benedict formula to predict energy requirements differs with weight history and ethnicity. Nutr Res. 2007 Apr;27(4):194-199. doi: 10.1016/j.nutres.2007.01.016.
PubMed 19081830Churchward-Venne TA, Burd NA, Mitchell CJ, West DW, Philp A, Marcotte GR, Baker SK, Baar K, Phillips SM. Supplementation of a suboptimal protein dose with leucine or essential amino acids: effects on myofibrillar protein synthesis at rest and following resistance exercise in men. J Physiol. 2012 Jun 1;590(11):2751-65. doi: 10.1113/jphysiol.2012.228833. Epub 2012 Mar 25.
PubMed 22451437Churchward-Venne TA, Breen L, Di Donato DM, Hector AJ, Mitchell CJ, Moore DR, Stellingwerff T, Breuille D, Offord EA, Baker SK, Phillips SM. Leucine supplementation of a low-protein mixed macronutrient beverage enhances myofibrillar protein synthesis in young men: a double-blind, randomized trial. Am J Clin Nutr. 2014 Feb;99(2):276-86. doi: 10.3945/ajcn.113.068775. Epub 2013 Nov 27.
PubMed 24284442Copeland KC, Kenney FA, Nair KS. Heated dorsal hand vein sampling for metabolic studies: a reappraisal. Am J Physiol. 1992 Nov;263(5):E1010-4. doi: 10.1152/ajpendo.1992.263.5.E1010.
PubMed 1443110Green JH, Ellis FR, Shallcross TM, Bramley PN. Invalidity of hand heating as a method to arterialize venous blood. Clin Chem. 1990 May;36(5):719-22.
PubMed 2337978Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.
PubMed 19589961Burd NA, West DW, Staples AW, Atherton PJ, Baker JM, Moore DR, Holwerda AM, Parise G, Rennie MJ, Baker SK, Phillips SM. Low-load high volume resistance exercise stimulates muscle protein synthesis more than high-load low volume resistance exercise in young men. PLoS One. 2010 Aug 9;5(8):e12033. doi: 10.1371/journal.pone.0012033.
PubMed 20711498Traylor DA, Kamal M, Nunes EA, Prior T, Gorissen SHM, Lees M, Gesel F, Lim C, Phillips SM. Consumption of High-Leucine-Containing Protein Bar Following Breakfast Impacts Aminoacidemia and Subjective Appetite in Older Persons. Curr Dev Nutr. 2021 May 8;5(6):nzab080. doi: 10.1093/cdn/nzab080. eCollection 2021 Jun.
PubMed 34104852
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of a Leucine-Enriched Dairy Protein Blend: Effects on Plasma Amino Acids in Older Adults
- ClinicalTrials.gov ID
- NCT03712761
- Acronym / sponsor ID
- 2502
- Conditions
- Healthy
- Keywords
- Dietary Protein Supplementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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.
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 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 determine post-ingestion aminoacidemia, glycemia, and insulinemia from a specially formulated dairy protein blend.
Detailed description
Experimental approach:
8 participants will be included in this study. Each participant will consume the supplement only once in a randomized fashion during three separate visits and there will be approximately 1 week between each visit.
Standardized meal:
Participants will be provided a standardized diet one day prior to experimentation. When performing research involving human metabolism it is important that the participants be tested in a weight-stable state. Therefore, the investigators will estimate the participants resting energy expenditure using a widely reference prediction formula, known as the Harris-Benedict equation. This formula takes into account gender, body mass, height, age, and self-reported activity level. Once resting energy expenditure is calculated the investigators will provide each participant with a pre-packaged standardized diet for the day prior to the experiment that is designed to ensure a sufficient energy balance.
Dual Energy X-Ray Absorptiometry (DXA) Scans:
DXA scans will be used to determine the participants body composition. The DXA procedures use a small amount of radiation to determine how much fat, bone, and lean mass the participants have in their body. The procedure takes approximately seven minutes and involves the participants lying still on an open bed while the sensor passes over the participants body.
Arterialized blood sampling:
All blood sampling will be achieved through an intravenous indwelling cannula. This method provides the least trauma to the participant when repeated blood sampling is required and is convenient for the investigators. In theory, repeated needle sticks may stress the participant thereby increasing sympathetic nervous system activity, thus causing changes in metabolism. Additionally, another potential drawback from venous blood sampling is the influence by regional tissue specific metabolism, thereby making it difficult to interpret whole-body metabolism on the basis of metabolites measured in venous blood. Therefore, arterial blood sampling is deemed the ideal method for metabolic studies. Arterial cannulation, however, may be unethical for research purposes due to increased risk of complications, such as damage to the arterial wall, thrombosis, and clot formation, all of which may cause death. Arterializing the blood being sampled can be achieved through heating either the superficial antecubital vein or dorsal hand vein with a heating blanket or specialized heat box. By doing so, blood flow increases as a result of vasodilatation of vessels in the arms skeletal musculature, as well as arteriovenous anastomoses in skin. Due to the increased blood flow and negligible muscle mass at the hand and elbow, results in venous blood being similar in composition to an arterial sample. This method is a widely used surrogate for safe direct arterial blood sampling. Once arterialized blood samples are obtained they will be preserved and used in analyses. The investigators will utilize heating blankets (Theratherm Large Digital Moist Heat Pad [14" x 27"]) to arterialize the blood samples and an infrared thermometer (Nubee, NUB8380) to determine the skin temperature (45-68∘C) prior to drawing the participant's blood.
Per-protocol conditions will include:
Consumption of a standardized meal the evening prior to each trial and consistent exercise/activity 2d before each trial There will be ~1wk between trials (washout periods) Blood samples will be analyzed for plasma amino acids, glucose, and insulin.
Experimental Interventions (randomized order):
- Participants will consume a Low Protein Containing Breakfast (10% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine) and 2 hours later the participants will consume 17g of a leucine enriched whey protein- hydrolyzed whey protein-micellar casein blend (50:43:7 whey:hydrolyzed-whey:casein) containing 600 IU Vitamin D and 3.5g leucine
- Participants will consume a High Protein Containing Breakfast (25% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine)
- Participants will consume a Low Protein Containing Breakfast (10% of the Acceptable Macronutrient Distribution Range according to the Food and Nutrition Board of the Institute of Medicine)
Proteins were provided by Covance Laboratories, Inc. owned by Eurofins.
The whey protein and micellar casein are milk proteins derived from cow's milk. The participants will consume the 17g of protein contained in a semi-solid bar equal to ∼40g, which is the size of a typical sports recovery bar.
Sample size and data analyses:
The sample size was determined by a statistical power analysis (G*Power 3.1 software, version 3.1.9, 2014) that revealed a large effect size. This study was powered on the basis of previous studies. Thus, a total of 8 (n = 8/group) participants will be used in analyses. See Below:
Analysis: A priori: Compute required sample size ANOVA: Repeated measures, within-between interaction Input Effect size f = 0.5 α err prob = 0.05 Power (1-β err prob) = 0.95 Number of groups = 3 Number of measurements = 14 Corr. Among rep. measures = 0.5 Nonsphericity correction ε = 1 Output Noncentrality parameter ƛ = 63 Critical F = 1.6380186 Numerator df = 26 Denominator df = 78 Total sample = 9 Actual power = 0.997
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supplementation with Enriched Protein® | – | Dietary Supplement: Enriched Protein®Participants will consume a low protein containing breakfast and 2 hours later will consume the enriched protein supplement |
| Low protein breakfast | – | –No supplementation |
| High protein breakfast | – | –No supplementation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Healthy Older Adults
Key inclusion criteria (1 listed)
- 8 participants will be included in this study. Each participant will consume the supplement only once in a randomized fashion during one of 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 or female, 65 years or older (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 |
|---|---|---|
| Enriched Protein®This product contains high quality bovine milk proteins enriched with additional leucine. | Dietary supplement | Supplementation with Enriched Protein® |
Primary outcome
Easy-fast amino acid sample testing kit for gas chromatography mass spectrometry
Time frame: 375 minutes
plasma amino acid concentrations
15 secondary outcomes
Hexokinase/G-6-PDH methodology
Time frame: 375 minutes
Chemiluminescent Microparticle Immunoassay
Time frame: 375 minutes
Visual Analog Scale Questionnaires for food sensory perception desire to eat
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for hunger
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for fullness
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for thirst
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for how much food could be eaten
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for liking or disliking of food
Time frame: Average score across 13 measurements
Visual Analog Scale Questionnaires for food sensory perception for visual appeal
Time frame: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for smell
Time frame: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for taste
Time frame: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for aftertaste
Time frame: Average score across 2 measurements
Visual Analog Scale Questionnaires for food sensory perception for pleasantness
Time frame: Average score across 2 measurements
Height in meters
Time frame: One measurement at baseline
Weight in kilograms
Time frame: One measurement at baseline
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 20 Jun 2024.
- Results publication: 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.
- Results publication: PubMed 19625697Koopman 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 9405716Boirie 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.
- Results publication: PubMed 19081830Douglas CC, Lawrence JC, Bush NC, Oster RA, Gower BA, Darnell BE. Ability of the Harris Benedict formula to predict energy requirements differs with weight history and ethnicity. Nutr Res. 2007 Apr;27(4):194-199. doi: 10.1016/j.nutres.2007.01.016.
- Results publication: PubMed 22451437Churchward-Venne TA, Burd NA, Mitchell CJ, West DW, Philp A, Marcotte GR, Baker SK, Baar K, Phillips SM. Supplementation of a suboptimal protein dose with leucine or essential amino acids: effects on myofibrillar protein synthesis at rest and following resistance exercise in men. J Physiol. 2012 Jun 1;590(11):2751-65. doi: 10.1113/jphysiol.2012.228833. Epub 2012 Mar 25.
- Results publication: PubMed 24284442Churchward-Venne TA, Breen L, Di Donato DM, Hector AJ, Mitchell CJ, Moore DR, Stellingwerff T, Breuille D, Offord EA, Baker SK, Phillips SM. Leucine supplementation of a low-protein mixed macronutrient beverage enhances myofibrillar protein synthesis in young men: a double-blind, randomized trial. Am J Clin Nutr. 2014 Feb;99(2):276-86. doi: 10.3945/ajcn.113.068775. Epub 2013 Nov 27.
- Results publication: PubMed 1443110Copeland KC, Kenney FA, Nair KS. Heated dorsal hand vein sampling for metabolic studies: a reappraisal. Am J Physiol. 1992 Nov;263(5):E1010-4. doi: 10.1152/ajpendo.1992.263.5.E1010.
- Results publication: PubMed 2337978Green JH, Ellis FR, Shallcross TM, Bramley PN. Invalidity of hand heating as a method to arterialize venous blood. Clin Chem. 1990 May;36(5):719-22.
- 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.
Stuart M Phillips, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, 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 1 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 20 Jun 2024. 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?
Easy-fast amino acid sample testing kit for gas chromatography mass spectrometry (time frame: 375 minutes). 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 NCT03712761, which also lists 15 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 20 Jun 2024.