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

Sponsor
University of Nottingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05700058
Collaborator
(none)
30
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3
5
6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary protein supplement
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" at Rest and in Response to Acute Exercise in Older Adults
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Super-Whey protein Dose 1

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

Other: Dietary protein supplement
3 different doses of super-whey protein supplements will be given in a randomised crossover fashion to participants

Experimental: Super-Whey protein Dose 2

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

Other: Dietary protein supplement
3 different doses of super-whey protein supplements will be given in a randomised crossover fashion to participants

Experimental: Super-Whey protein Dose 3

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

Other: Dietary protein supplement
3 different doses of super-whey protein supplements will be given in a randomised crossover fashion to participants

Outcome Measures

Primary Outcome Measures

  1. Muscle protein fractional synthetic rate (postabsorptive) [Assessed at 3 hour mark]

    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.

  2. Muscle protein fractional synthetic rate (postprandial) [Assessed at 6 hour mark]

    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

  1. Plasma amino acid concentrations [Assessed over 7.5 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre of Ageing, Metabolism and Physiology Derby United Kingdom DE22 3DT

Sponsors and Collaborators

  • University of Nottingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Atherton, Professor, University of Nottingham
ClinicalTrials.gov Identifier:
NCT05700058
Other Study ID Numbers:
  • ARLA-WHEY_PtB_COMAP
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023