CClinicalTrials.gg
CompletedNCT02912130Updated Sep 11, 2025

Exercise and Nutrition Interventions in Age-related Sarcopenia

An interventional study of Protein Supplementation and Aerobic Exercise in Sarcopenia and Muscular Atrophy, sponsored by Liverpool Hope University. Completed at 1 site in United Kingdom. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Liverpool Hope University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study summary

This project will investigate the synergistic effects of Aerobic and Resistance type Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.

Read the detailed description

Musculoskeletal ageing is an inevitable process associated with profound morphological and functional changes that will ultimately transition an individual from independent, to dependable living, relying heavily on personal health care for survival. The United Kingdom (UK) population aged over 65 years is expected to rise from 8.8 to 11.3 million by 2025. As life expectancy increases due to advances in medical treatment, an age-related disease termed sarcopenia, has become more prevalent in the elderly. Sarcopenia, described as the loss of musculoskeletal mass, strength and/or physical functioning with age, manifests after the 6th decade and rapidly increases after the 8th decade, resulting in a deterioration of health status and quality of life. To manage the looming health and economic consequences of sarcopenia, suitable therapeutic strategies to manage the condition are warranted. Therefore, this randomised control trial (RCT) will investigate the effects of 16-weeks of exercise and nutritional interventions in inactive senior citizens (60 - 90 years old).

02

Conditions studied

  • Sarcopenia
  • Muscular Atrophy

Keywords

  • Exercise
  • Nutrition
  • Sarcopenia
  • Healthy Ageing
  • Elderly
  • Muscular Hypertrophy
03

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and Female participants
  • 60 - 90 years of age
  • Resident in North West, England, UK
  • BMI 18.5-30 kg/m
  • Can speak and understand English
  • Willing to consent and follow the study procedures

Exclusion criteria

Exclusion Criteria:

  • Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary and/or exercise intervention program
  • Self-reported lactose intolerance
  • Uncontrolled diabetes (HbA1C >10)
  • Uncontrolled Hypertension (160/100) and uncontrolled hypotension (\<100 systolic)
  • Treatment with Beta Blockers, Calcium Channel Blockers, Digitalis, Bronchodilator,
  • Diuretics, Vasodilators
  • Current hormone therapy such as insulin, testosterone or hormone replacement therapy
  • History of falls/osteoporosis
  • Major psychological/mental illness
  • Medical conditions that precluded safe participation in an exercise program
  • Other major systemic diseases: Liver and kidney diseases, Advanced gastrointestinal disorders, Cardiovascular Diseases, Advanced chronic obstructive pulmonary disease, Advanced Rheumatoid Arthritis, Cancer
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • No intervention
    Control

    No Intervention

  • Experimental
    Exercise

    1. Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise 2. Resistance Exercise i.e. 60 minutes per week of progressive resistance training

    Other: Aerobic Exercise · Other: Resistance Exercise

  • Experimental
    Exercise+Nutrition

    1. Aerobic Exercise i.e. 30-60 minutes per week of moderate intensity exercise 2. Dietary Supplement i.e. Protein Supplementation 1.2-1.5g/kg/body weight per day

    Dietary Supplement: Protein Supplementation · Other: Aerobic Exercise · Other: Resistance Exercise

  • Experimental
    Nutrition

    Dietary Supplement: Protein Supplementation i.e. 1.2-1.5g/kg/body weight per day

    Dietary Supplement: Protein Supplementation

Interventions

  • Dietary supplementProtein Supplementation

    1.2-1.5g/kg/body weight per day

  • OtherAerobic Exercise

    30-60 minutes per week of moderate intensity exercise

  • OtherResistance Exercise

    60 minutes per week of progressive resistance training

05

What researchers measure

Primary outcomes

  1. Body Composition: Lean Muscle/Fat Tissue 1) appendicular lean mass (kg) divided by height (meters-squared) and 2) appendicular lean mass divided by body mass index

    Time frame: 16 weeks

Secondary outcomes

  1. Grip Strength: Hand Grip Dynanometer (kg)

    Time frame: 16 weeks

  2. Gait speed during timed 4-meter walk (m/s)

    Time frame: 16 Weeks

  3. Time to complete five chair rises (m/s)

    Time frame: 16 Weeks

  4. Balance assessment: 1) feet side to side, 2) semi-tandem, 3) full tandem, and 4) single leg. Scored as Yes or No.

    Time frame: 16 Weeks

  5. Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)

    Time frame: 16 Weeks

  6. Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)

    Time frame: 16 Weeks

  7. Exercise Tolerance: Six Minute Walk Test (metres)

    Time frame: 16 Weeks

  8. 10-metre Gait analysis during habitual walking speed using Electromyography (EMG)

    Time frame: 16 Weeks

  9. 10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics

    Time frame: 16 Weeks

  10. Biochemical: Glycated Haemoglobin (HBA1c) (%)

    Time frame: 16 Weeks

  11. Biochemical: C-Reactive Protein (CRP) (mg/L)

    Time frame: 16 Weeks

  12. Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)

    Time frame: 16 Weeks

  13. Arterial Pressure: Pulse Wave Velocity (m/s)

    Time frame: 16 Weeks

  14. Energy Balance: Periodic Food Diary (Kcal)

    Time frame: 16 Weeks

  15. World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale

    Time frame: 16 Weeks

  16. Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale

    Time frame: 16 Weeks

  17. Activities of Daily Living (ADL): Each response is scored as either: 0 or 1

    Time frame: 16 Weeks

  18. Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point

    Time frame: 16 Weeks

  19. Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)

    Time frame: 16 weeks

06

Study locations

1 site
  • Liverpool Hope University
    Liverpool, Merseyside L16 9JD, United Kingdom
07

References and documents

Publications

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. PubMed 20392703 ↗
  • Witard OC, Wardle SL, Macnaughton LS, Hodgson AB, Tipton KD. Protein Considerations for Optimising Skeletal Muscle Mass in Healthy Young and Older Adults. Nutrients. 2016 Mar 23;8(4):181. doi: 10.3390/nu8040181. PubMed 27023595 ↗
  • Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23. PubMed 25539836 ↗
  • Yu SC, Khow KS, Jadczak AD, Visvanathan R. Clinical Screening Tools for Sarcopenia and Its Management. Curr Gerontol Geriatr Res. 2016;2016:5978523. doi: 10.1155/2016/5978523. Epub 2016 Feb 4. PubMed 26966433 ↗
  • Churchward-Venne TA, Holwerda AM, Phillips SM, van Loon LJ. What is the Optimal Amount of Protein to Support Post-Exercise Skeletal Muscle Reconditioning in the Older Adult? Sports Med. 2016 Sep;46(9):1205-12. doi: 10.1007/s40279-016-0504-2. PubMed 26894275 ↗
  • Kraschnewski JL, Sciamanna CN, Poger JM, Rovniak LS, Lehman EB, Cooper AB, Ballentine NH, Ciccolo JT. Is strength training associated with mortality benefits? A 15year cohort study of US older adults. Prev Med. 2016 Jun;87:121-127. doi: 10.1016/j.ypmed.2016.02.038. Epub 2016 Feb 24. PubMed 26921660 ↗
  • Witard OC, McGlory C, Hamilton DL, Phillips SM. Growing older with health and vitality: a nexus of physical activity, exercise and nutrition. Biogerontology. 2016 Jun;17(3):529-46. doi: 10.1007/s10522-016-9637-9. Epub 2016 Feb 15. PubMed 26878863 ↗
  • Chang SF, Lin PL. Systematic Literature Review and Meta-Analysis of the Association of Sarcopenia With Mortality. Worldviews Evid Based Nurs. 2016 Apr;13(2):153-62. doi: 10.1111/wvn.12147. Epub 2016 Feb 4. PubMed 26844538 ↗
  • Csapo R, Alegre LM. Effects of resistance training with moderate vs heavy loads on muscle mass and strength in the elderly: A meta-analysis. Scand J Med Sci Sports. 2016 Sep;26(9):995-1006. doi: 10.1111/sms.12536. Epub 2015 Aug 24. PubMed 26302881 ↗
  • Xu ZR, Tan ZJ, Zhang Q, Gui QF, Yang YM. Clinical effectiveness of protein and amino acid supplementation on building muscle mass in elderly people: a meta-analysis. PLoS One. 2014 Sep 30;9(9):e109141. doi: 10.1371/journal.pone.0109141. eCollection 2014. PubMed 25268791 ↗
  • Komar B, Schwingshackl L, Hoffmann G. Effects of leucine-rich protein supplements on anthropometric parameter and muscle strength in the elderly: a systematic review and meta-analysis. J Nutr Health Aging. 2015 Apr;19(4):437-46. doi: 10.1007/s12603-014-0559-4. PubMed 25809808 ↗
  • Ko SU, Hausdorff JM, Ferrucci L. Age-associated differences in the gait pattern changes of older adults during fast-speed and fatigue conditions: results from the Baltimore longitudinal study of ageing. Age Ageing. 2010 Nov;39(6):688-94. doi: 10.1093/ageing/afq113. Epub 2010 Sep 10. PubMed 20833863 ↗
  • Kirk B, Mooney K, Vogrin S, Jackson M, Duque G, Khaiyat O, Amirabdollahian F. Leucine-enriched whey protein supplementation, resistance-based exercise, and cardiometabolic health in older adults: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):2022-2033. doi: 10.1002/jcsm.12805. Epub 2021 Sep 14. PubMed 34520104 ↗
  • Kirk B, Mooney K, Amirabdollahian F, Khaiyat O. Exercise and Dietary-Protein as a Countermeasure to Skeletal Muscle Weakness: Liverpool Hope University - Sarcopenia Aging Trial (LHU-SAT). Front Physiol. 2019 Apr 25;10:445. doi: 10.3389/fphys.2019.00445. eCollection 2019. PubMed 31133863 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT02912130
Lead sponsor
Liverpool Hope University
Responsible party
Omid Khaiyat, MD, PhD (Dr, Liverpool Hope University) — Principal investigator
First posted
Sep 23, 2016
Start date
Sep 2016
Primary completion
Dec 2023
Completion
Dec 2023
Last update
Sep 11, 2025

Study contacts

Dr Omid Alizadehkhaiyat, MD, PhD
principal investigator · Liverpool Hope University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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