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Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis (ARLA-WHEY)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Super-Whey protein
Isonitrogenous whey protein
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

18 Years - 85 Years (Adult, 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 Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Super-Whey protein

Isonitrogenous whey protein

Arm Description

Both 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

Both 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
August 4, 2021
Last Updated
January 17, 2023
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT05701202
Brief Title
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis
Acronym
ARLA-WHEY
Official Title
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis at Rest and in Response to Acute Resistance Exercise Across the Lifespan
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)

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 whether a novel whey protein with greater leucine content ("super-whey") has superior muscle building properties compared to a regular whey protein, at rest and after a single bout of exercise, in both young and 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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Super-Whey protein
Arm Type
Experimental
Arm Description
Both 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
Isonitrogenous whey protein
Arm Type
Active Comparator
Arm Description
Both 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
Dietary Supplement
Intervention Name(s)
Super-Whey protein
Intervention Description
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
Intervention Type
Dietary Supplement
Intervention Name(s)
Isonitrogenous whey protein
Intervention Description
2 different protein supplements (as above) 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
18 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Atherton, Prof
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Ageing, Metabolism and Physiology
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis

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