Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05701202
Other study ID # ARLA-WHEY_PtA_CMMP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date November 22, 2022

Study information

Verified date January 2023
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
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 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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 22, 2022
Est. primary completion date November 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Super-Whey protein
2 different protein supplements (as above) will be given in a randomised crossover fashion to participants
Isonitrogenous whey protein
2 different protein supplements (as above) 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Recruiting NCT05008770 - Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease