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Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults (ARLA-WHEY)

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary protein supplement
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sarcopenia

Eligibility Criteria

65 Years - 85 Years (Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years). Participant is willing and able to give informed consent for participation in the study. Participant is physically able to perform resistance exercise Exclusion Criteria: A BMI <18 or >35 kg/m2 Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke Any metabolic disease Clotting dysfunction A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy) Lactose intolerance Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Sites / Locations

  • Centre of Ageing, Metabolism and PhysiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Super-Whey protein Dose 1

Super-Whey protein Dose 2

Super-Whey protein Dose 3

Arm Description

All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations

All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations

All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations

Outcomes

Primary Outcome Measures

Muscle protein fractional synthetic rate (postabsorptive)
Postabsorptive measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed prior to administering a protein drink to obtain muscle protein fractional synthetic rate in the fasted state.
Muscle protein fractional synthetic rate (postprandial)
Postprandial measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed following administering a protein drink to obtain muscle protein fractional synthetic rate in the fed state.

Secondary Outcome Measures

Plasma amino acid concentrations
During the fasted and fed states of the study, blood samples are collected every 20 minutes to capture the plasma amino acid concentrations in the blood at that time-point (24 timepoints assessed). Future analysis using mass-spectroscopy will allow determination of the different amino acid concentrations in the blood plasma collected.

Full Information

First Posted
January 17, 2023
Last Updated
January 17, 2023
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT05700058
Brief Title
Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults
Acronym
ARLA-WHEY
Official Title
Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" at Rest and in Response to Acute Exercise in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. Despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). As such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. Leucine, an essential and branched chain amino acid (EAA/BCAA), is thought to be the most potent AA for stimulating muscle protein synthesis (MPS; the muscle building process). Although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of MPS, low doses of leucine-enriched mixed-EAAs can elicit similar increases in MPS as compared to a large dose of whey protein. As reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate MPS may contribute to muscle health maintenance in older adults and reduce satiation following a meal. This study aims to examine which of three doses of a novel leucine-enriched whey protein ("super-whey") best stimulates muscle building in older adults

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Super-Whey protein Dose 1
Arm Type
Experimental
Arm Description
All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations
Arm Title
Super-Whey protein Dose 2
Arm Type
Experimental
Arm Description
All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations
Arm Title
Super-Whey protein Dose 3
Arm Type
Experimental
Arm Description
All protein sources will be given in doses that are considered low/normal, both in relation to recommended dietary advice and commercially available supplements. As such, no adverse reactions or side effects are expected through consumption of these supplementations
Intervention Type
Other
Intervention Name(s)
Dietary protein supplement
Intervention Description
3 different doses of super-whey protein supplements will be given in a randomised crossover fashion to participants
Primary Outcome Measure Information:
Title
Muscle protein fractional synthetic rate (postabsorptive)
Description
Postabsorptive measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed prior to administering a protein drink to obtain muscle protein fractional synthetic rate in the fasted state.
Time Frame
Assessed at 3 hour mark
Title
Muscle protein fractional synthetic rate (postprandial)
Description
Postprandial measures of muscle protein synthesis assessed in muscle tissue (collected by muscle biopsy). This outcome will be assessed following administering a protein drink to obtain muscle protein fractional synthetic rate in the fed state.
Time Frame
Assessed at 6 hour mark
Secondary Outcome Measure Information:
Title
Plasma amino acid concentrations
Description
During the fasted and fed states of the study, blood samples are collected every 20 minutes to capture the plasma amino acid concentrations in the blood at that time-point (24 timepoints assessed). Future analysis using mass-spectroscopy will allow determination of the different amino acid concentrations in the blood plasma collected.
Time Frame
Assessed over 7.5 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years). Participant is willing and able to give informed consent for participation in the study. Participant is physically able to perform resistance exercise Exclusion Criteria: A BMI <18 or >35 kg/m2 Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke Any metabolic disease Clotting dysfunction A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy) Lactose intolerance Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Facility Information:
Facility Name
Centre of Ageing, Metabolism and Physiology
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Atherton, Prof
Phone
+44 1332 724725
Email
Philip.Atherton@nottingham.ac.uk

12. IPD Sharing Statement

Learn more about this trial

Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults

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