Exercise and Nutrition Interventions in Age-related Sarcopenia

NCT ID: NCT02912130

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Sarcopenia Muscular Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

30-60 minutes per week of moderate intensity exercise

Resistance Exercise

Intervention Type OTHER

60 minutes per week of progressive resistance training

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

Group Type EXPERIMENTAL

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

1.2-1.5g/kg/body weight per day

Aerobic Exercise

Intervention Type OTHER

30-60 minutes per week of moderate intensity exercise

Resistance Exercise

Intervention Type OTHER

60 minutes per week of progressive resistance training

Nutrition

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

Group Type EXPERIMENTAL

Protein Supplementation

Intervention Type DIETARY_SUPPLEMENT

1.2-1.5g/kg/body weight per day

Interventions

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Protein Supplementation

1.2-1.5g/kg/body weight per day

Intervention Type DIETARY_SUPPLEMENT

Aerobic Exercise

30-60 minutes per week of moderate intensity exercise

Intervention Type OTHER

Resistance Exercise

60 minutes per week of progressive resistance training

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool Hope University

OTHER

Sponsor Role lead

Responsible Party

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Omid Khaiyat, MD, PhD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Omid Alizadehkhaiyat, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Hope University

Locations

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Liverpool Hope University

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 20392703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27023595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25539836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26966433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26894275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26921660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26878863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26844538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26302881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25268791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25809808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20833863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34520104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31133863 (View on PubMed)

Other Identifiers

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LiverpoolHU

Identifier Type: -

Identifier Source: org_study_id

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