NCT02053441

Brief Summary

In this study will measure differences in how muscle responds to both exercise and protein supplements in healthy women aged 60-69. We are studying two different protein supplements- a standard Whey Protein and a Leucine enriched supplement. Each patient would receive either one of these.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5.7 years

First QC Date

January 28, 2014

Last Update Submit

March 31, 2020

Conditions

Sarcopenia

Keywords

Muscle Protein SynthesisMuscle Protein Breakdown

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis and muscle protein breakdown

    Markers of muscle protein synthesis and breakdown are determined from muscle biopsy samples in form of myofibrillar Fractional Synthetic Rate (FSR) assessed by gas-chromatography-combustion-mass spectrometry, using incorporation of a stable isotope tracer (13-C-6 Phe)

    7 Hours

Secondary Outcomes (1)

  • Blood flow (bulk and nutritive) and intramuscular cell signalling

    7 Hours

Eligibility Criteria

Age60 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy females aged 60-70

You may qualify if:

  • Healthy post-menopausal females aged 60-70

You may not qualify if:

  • Obvious muscle wasting.
  • A body mass index (BMI) \< 18 or \> 40 kg•m2.
  • Active cardiovascular disease: uncontrolled high blood pressure, angina, heart failure (class III/IV), abnormal heart rhythm, right to left cardiac shunt or recent cardiac event.
  • Taking statin-based medication above 60mg•day-1.
  • Individuals taking beta-adrenergic blocking agents or Non-steroidal anti-inflammatory agents (NSAIDS)
  • Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
  • Respiratory disease including pulmonary hypertension, chronic obstructive pulmonary disease (COPD), asthma or a forced expiratory volume (FEV1) less than 1.5 litres.
  • Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
  • Active inflammatory bowel disease, renal disease, or malignancy.
  • Recent steroid treatment (within 6 months), or hormone replacement therapy.
  • Clotting dysfunction e.g. Deep vein thrombosis, pulmonary embolus, warfarin therapy and/ or haemophilia.
  • Musculoskeletal or neurological disorders.
  • Any leg amputated
  • Family history of early (\<55y) death from cardiovascular disease.
  • Known sensitivity to SONOVUE (US contrast).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham (Derby campus)

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Related Publications (2)

  • Wilkinson DJ, Bukhari SSI, Phillips BE, Limb MC, Cegielski J, Brook MS, Rankin D, Mitchell WK, Kobayashi H, Williams JP, Lund J, Greenhaff PL, Smith K, Atherton PJ. Effects of leucine-enriched essential amino acid and whey protein bolus dosing upon skeletal muscle protein synthesis at rest and after exercise in older women. Clin Nutr. 2018 Dec;37(6 Pt A):2011-2021. doi: 10.1016/j.clnu.2017.09.008. Epub 2017 Sep 23.

    PMID: 29031484RESULT

  • Bukhari SS, Phillips BE, Wilkinson DJ, Limb MC, Rankin D, Mitchell WK, Kobayashi H, Greenhaff PL, Smith K, Atherton PJ. Intake of low-dose leucine-rich essential amino acids stimulates muscle anabolism equivalently to bolus whey protein in older women at rest and after exercise. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1056-65. doi: 10.1152/ajpendo.00481.2014. Epub 2015 Mar 31.

    PMID: 25827594RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for Glucose and RNA analysis Muscle biopsies for protein synthesis

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Kenneth Smith, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Student

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 3, 2014

Study Start

January 1, 2013

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

April 3, 2020

Record last verified: 2020-03

Locations

GB(1)