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

Sarcopenia Clinical Trial

— ARLA-WHEY  

Official title:

Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" at Rest and in Response to Acute Exercise in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700058
• Other study ID #: ARLA-WHEY_PtB_COMAP
• Status: Recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: June 2023

Study information

• Verified date: January 2023
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Centre of Ageing, Metabolism and Physiology	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Assessed over 7.5 hours