NCT05701202

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

August 4, 2021

Last Update Submit

January 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Assessed at 3 hour mark

  • 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.

    Assessed at 6 hour mark

Secondary Outcomes (1)

  • Plasma amino acid concentrations

    Assessed over 7.5 hours

Study Arms (2)

Super-Whey protein

EXPERIMENTAL

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

Dietary Supplement: Super-Whey protein

Isonitrogenous whey protein

ACTIVE COMPARATOR

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

Dietary Supplement: Isonitrogenous whey protein

Interventions

Super-Whey proteinDIETARY_SUPPLEMENT

2 different protein supplements (as above) will be given in a randomised crossover fashion to participants

Super-Whey protein
Isonitrogenous whey proteinDIETARY_SUPPLEMENT

2 different protein supplements (as above) will be given in a randomised crossover fashion to participants

Isonitrogenous whey protein

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Ageing, Metabolism and Physiology

Derby, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Philip Atherton, Prof

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2021

First Posted

January 27, 2023

Study Start

June 15, 2021

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations