Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People (Dunhill01)

This study has been completed.
Sponsor:
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01734616
First received: November 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70% of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require strength, keep the body balanced and continue activity for a prolonged period, which together may contribute to a loss of independence and an increased risk of falls. The cause of some of this muscle loss with ageing appears to be a reduction in muscle building in response to food. The known decreased limb blood flow in ageing muscle may go some way to explain this as there may be less nutrient delivery to the muscles. The investigators want to test if the known decrease in limb blood flow with age is matched with a decrease in the proportion of blood being delivered directly to the muscles, rather than fat and connective tissue. If so the investigators expect to see an improvement in the ability of muscles to maintain themselves via better capture of amino acids into protein. The investigators also want to test if 20 weeks resistance exercise training or drinking a cocktail of mixture of high flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood flow to older muscles and help reduce muscle wasting.


Condition Intervention
Regional Blood Flow
Behavioral: Old Exercise
Dietary Supplement: Old Acute Cocoa
Dietary Supplement: Old 7 Day Cocoa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Microvascular blood volume in response to feeding [ Time Frame: September 2009 - August 2012 ] [ Designated as safety issue: No ]
    The final study participant was completed and all microvascular blood volume data analysed by August 2012. This outcome measure is applicable to all arms of this study and refers to responsiveness to a 2 hour feed protocol.


Secondary Outcome Measures:
  • Muscle protein metabolism in response to feeding [ Time Frame: January - October 2012 ] [ Designated as safety issue: No ]
    Muscle protein metabolism (synthesis and breakdown) in response to feeding in young and older individuals and in older individuals after exercise or nutraceutical intervention. This outcome measure could only be assessed after all studies were completed to ensure standardization of mass-spectrometry measurements between the groups.


Other Outcome Measures:
  • Molecular pathways regulating muscle microvascular blood volume [ Time Frame: August 2012 - August 2013 ] [ Designated as safety issue: No ]
    This outcome measure was not able to be analysed prior to completion of all studied and the subsequent primary and secondary outcome measures as molecular targets of interest were dependent upon these results. This analysis has began and should be complete by August 2013.


Enrollment: 50
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Young
Young subjects to be controlled to older individuals with interventions
No Intervention: Old
Older individuals to compare to young and other older intervention groups
Experimental: Old Exercise
Older individuals studied after an intervention of 20 weeks fully-supervised resistance exercise training
Behavioral: Old Exercise
Experimental: Old Acute Cocoa
Older individuals studied with the addition of cocoa flavanols during their acute study
Dietary Supplement: Old Acute Cocoa
Experimental: Old 7 Day Cocoa
Older individuals studied after 7 day supplementation of cocoa flavanols
Dietary Supplement: Old 7 Day Cocoa

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy volunteers aged 18-28 or 65-75

Exclusion Criteria:

  • Overt muscle wasting i.e. muscle mass is more than 1 standard deviation below normal muscle or FFM for age
  • A BMI < 24 or > 28 kg•m2.
  • Active cardiovascular disease: uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
  • Individuals taking beta-adrenergic blocking agents.
  • Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
  • Respiratory disease including pulmonary hypertension, COPD, asthma or an FEV1 less than 1.5 l.
  • Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
  • Active inflammatory bowel disease, or renal disease,
  • Malignancy
  • Recent steroid treatment (within 6 mo), or hormone replacement therapy.
  • Clotting dysfunction
  • Musculoskeletal or neurological disorders.
  • Family history of early (<55y) death from cardiovascular disease
  • Known sensitivity to Definity or methacholine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734616

Locations
United Kingdom
Clinical Physiology Laboratory, Graduate Entry Medical School, University of Nottingham, Royal Derby Hospital
Derby, Derbyshire, United Kingdom, DE22 3DT
Sponsors and Collaborators
University of Nottingham
The Dunhill Medical Trust
Investigators
Principal Investigator: John P Williams, PhD, MD University of Nottingham
Study Director: Bethan E Phillips, PhD University of Nottingham
  More Information

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01734616     History of Changes
Other Study ID Numbers: F/3/2009
Study First Received: November 21, 2012
Last Updated: November 27, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Microvascular
Muscle
Nutrition
Exercise
Ageing

ClinicalTrials.gov processed this record on August 28, 2014