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Supplementation of a Leucine-Enriched Dairy Protein Blend

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ClinicalTrials.gov Identifier: NCT03712761
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Stuart Phillips, McMaster University

Brief 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. 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.

Condition or disease Intervention/treatment
Healthy Dietary Supplement: Enriched Protein®

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Supplementation of a Leucine-Enriched Dairy Protein Blend: Effects on Plasma Amino Acids in Older Adults
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Proteins
Drug Information available for: Leucine

Group/Cohort Intervention/treatment
Supplementation with Enriched Protein®
Participants will consume a low protein containing breakfast and 2 hours later will consume the enriched protein supplement
Dietary Supplement: Enriched Protein®
This product contains high quality bovine milk proteins enriched with additional leucine.

Low protein breakfast
No supplementation
High protein breakfast
No supplementation



Primary Outcome Measures :
  1. Easy-fast amino acid sample testing kit for gas chromatography mass spectrometry [ Time Frame: 375 minutes ]
    plasma amino acid concentrations


Secondary Outcome Measures :
  1. Hexokinase/G-6-PDH methodology [ Time Frame: 375 minutes ]
    plasma glucose concentrations

  2. Chemiluminescent Microparticle Immunoassay [ Time Frame: 375 minutes ]
    plasma insulin concentrations

  3. Visual Analog Scale Questionnaires for food sensory perception desire to eat [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score

  4. Visual Analog Scale Questionnaires for food sensory perception for hunger [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score

  5. Visual Analog Scale Questionnaires for food sensory perception for fullness [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score

  6. Visual Analog Scale Questionnaires for food sensory perception for thirst [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score

  7. Visual Analog Scale Questionnaires for food sensory perception for how much food could be eaten [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = lowest score and 100mm = highest score

  8. Visual Analog Scale Questionnaires for food sensory perception for liking or disliking of food [ Time Frame: Average score across 13 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  9. Visual Analog Scale Questionnaires for food sensory perception for visual appeal [ Time Frame: Average score across 2 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  10. Visual Analog Scale Questionnaires for food sensory perception for smell [ Time Frame: Average score across 2 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  11. Visual Analog Scale Questionnaires for food sensory perception for taste [ Time Frame: Average score across 2 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  12. Visual Analog Scale Questionnaires for food sensory perception for aftertaste [ Time Frame: Average score across 2 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  13. Visual Analog Scale Questionnaires for food sensory perception for pleasantness [ Time Frame: Average score across 2 measurements ]
    Units on a 100mm Paper Scale, 0mm = worst score and 100mm = best score

  14. Height in meters [ Time Frame: One measurement at baseline ]
    Stadiometer

  15. Weight in kilograms [ Time Frame: One measurement at baseline ]
    Physician scale


Biospecimen Retention:   Samples Without DNA
Blood plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy Older Adults
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712761


Locations
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Canada, Ontario
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Stuart M Phillips, PhD McMaster University

Publications of Results:

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Responsible Party: Stuart Phillips, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03712761     History of Changes
Other Study ID Numbers: 2502
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stuart Phillips, McMaster University:
Dietary Protein Supplementation