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

NCT05700058 | Recruiting

• 1 other identifier: ARLA-WHEY_PtB_COMAP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia

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 (3)

Super-Whey protein Dose 1

EXPERIMENTAL

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. This protein dose will be 5 g protein and will be given as a single bolus dose.

Other: Dietary protein supplement

Super-Whey protein Dose 2

EXPERIMENTAL

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. This protein dose will be 10 g protein and will be given as a single bolus dose.

Other: Dietary protein supplement

Super-Whey protein Dose 3

EXPERIMENTAL

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. This protein dose will be 20 g protein and will be given as a single bolus dose.

Other: Dietary protein supplement

Interventions

Dietary protein supplement OTHER

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

Super-Whey protein Dose 1; Super-Whey protein Dose 2; Super-Whey protein Dose 3

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Centre of Ageing, Metabolism and Physiology

Derby, DE22 3DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: January 31, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

GB (1)