NCT05574205

Brief Summary

Dietary proteins potently augment muscle protein synthesis. Because of poorer anabolic sensitivity with ageing, studies and guidelines recommend higher dietary protein intake for older adults. Although higher doses would benefit skeletal muscle remodelling, large protein consumption is not feasible for many older adults. To circumvent, high-protein quality which possesses a high amino acid profile and digestibility appears to have an emergent role for supporting anabolism. Since currently the best line of defence against age related muscle loss is resistance exercise training and regular protein consumption, emphasising high-quality protein ingestion, such as whey protein, within meals may be feasible and efficacious in supporting musculoskeletal remodelling in older adults, without requirement for large protein doses. The investigators propose that at low doses, high quality protein will have additive benefit to muscle protein synthesis compared to low-quality protein. Further, combining high-quality protein diets with resistance exercise training will have more profound benefits for muscle protein synthesis and muscle remodelling more so than low-quality protein diets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

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

November 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

September 29, 2022

Last Update Submit

July 31, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Muscle protein synthesis using muscle biopsies and deuterated water enrichment.

    Muscle protein synthesis will be assessed during the high-quality and low-quality intervention and compared between exercised and controlled leg.

    0-10 days

  • Leg Strength using dynamometry

    Evaluating change in leg strength, of trained leg, pre- and post-intervention with high-quality and low-quality protein condition

    0-10 days

  • Neural activation using interpolated twitch

    Assessing change in neural activation via non-invasive interpolated twitch technique of between exercised legs pre-and post intervention in both protein quality conditions

    0-10 days

  • Muscle architecture using ultrasound

    Using non-invasive ultrasound to determine change of muscle structure with training between protein quality conditions.

    0-10 days

Secondary Outcomes (8)

  • Appetite regulation using questionnaires

    0-10 days (3 hours postprandial)

  • Appetite regulation, blood

    0-10 days (3 hours postprandial)

  • Metabolic rate, metabolic cart

    0-10 days

  • Nitrogen balance from urine and dietary protein intake

    0-10 days (24-hour urine collection)

  • Body composition using Duel- energy x-ray absorptiometry (DXA) scan.

    0-10 days

  • +3 more secondary outcomes

Study Arms (2)

High Quality Protein

EXPERIMENTAL

Participants will consume four high-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 75:25 animal:plant protein with most of the animal protein from supplemental high-quality protein powder.

Other: Resistance ExerciseDietary Supplement: Protein supplementation

Low Quality Protein

EXPERIMENTAL

Participants will consume four low-quality protein containing meals per day (amounting to 1g/kg/day of protein) over a 10-day period. Each meal will contain 25:75 animal:plant protein with most of the plant protein from supplemental low-quality protein powder.

Other: Resistance ExerciseDietary Supplement: Protein supplementation

Interventions

Supervised single-leg (unilateral) exercise will be undertaken every other day throughout the dietary intervention

Also known as: Single-leg resistance exercise
High Quality ProteinLow Quality Protein
Protein supplementationDIETARY_SUPPLEMENT

Participants will consume a protein supplement alongside a provided diet to control protein amount and quality.

High Quality ProteinLow Quality Protein

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and Females aged between 50-70 years
  • Accustomed to normal physical activity levels (averaging at least 7000 steps a day)
  • Healthy body mass (i.e., BMI 18-25 kg/m2)
  • General good health indicated by health questionnaire
  • Free from COVID-19 (SARS-CoV-2) symptoms.

You may not qualify if:

  • Habitually high consumers of protein (\>1.6g/kg/day) assessed by habitual diet diary
  • Food allergies
  • Lidocaine allergy
  • Smoker
  • Bleeding Disorders
  • Chronic/systemic illnesses (i.e., renal failure, rheumatoid arthritis, diabetes, poor lung function, heart disease, cancer, uncontrolled hypertension)
  • Regular consumption of any analgesic or anti-inflammatory drugs. Taking medications mknown to affect muscle metabolis (e.g. beta-blockers, corticosteroids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences

Edgbaston, West Midlands, B15 2TT, United Kingdom

Location

Related Publications (1)

  • Korzepa M, Quinlan JI, Marshall RN, Rogers LM, Belfield AE, Elhassan YS, Lawson A, Ayre C, Senden JM, Goessens JP, Glover EI, Wallis GA, van Loon LJ, Breen L. Resistance training increases myofibrillar protein synthesis in middle-to-older aged adults consuming a typical diet with no influence of protein source: a randomized controlled trial. Am J Clin Nutr. 2025 Jul;122(1):122-136. doi: 10.1016/j.ajcnut.2025.04.019. Epub 2025 Apr 25.

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will not know which condition they are under due to the contribution of animal and plant based elements within the diet, the conditions are not immediately obvious. Further, the higher and lower quality supplemental drinks have been made so the taste and texture of which are not discernible. The randomisation and counterbalancing will be done by a researcher separate to the project, using anonymised participant codes. The condition participants are under will be also completed before inducting participants. Researchers will be blinded to the condition and which leg was exercised during the analysis.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the high-quality or low-quality condition. Within both conditions single-leg resistance exercise will be undertaken meaning the other non-exercise leg for each participant will act as their own internal control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 10, 2022

Study Start

November 1, 2021

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

August 1, 2024

Record last verified: 2021-09

Locations