Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)

This study is currently recruiting participants.
Verified February 2014 by Tufts University
Sponsor:
Collaborators:
Uppsala University
Karolinska Institutet
Nestec Ltd.
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01542892
First received: February 27, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.


Condition Intervention Phase
Sarcopenia
Other: Exercise Intervention
Dietary Supplement: Supplement Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Time to Walk 400 meters [ Time Frame: 6-Month ] [ Designated as safety issue: No ]
    The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in <15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.


Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement Dietary Supplement: Supplement Intervention
Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
Sham Comparator: Placebo Dietary Supplement: Supplement Intervention
Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
Experimental: Exercise Other: Exercise Intervention
Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.

Detailed Description:

Exercise Intervention: Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.

Supplement Intervention: Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.

Primary Outcome: The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in <15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.

Secondary Outcome Measures:

  • Stair Climb Test
  • Body Composition
  • Skeletal muscle cross sectional area
  • Isokinetic/Isometric peak torque/power
  • Hand-grip strength
  • Nutritional status
  • Quality of Life/Depressive symptoms Expected enrollment: 150 (80 at Tufts University (Boston, MA, USA), 70 at University of Uppsala (Uppsala, Sweden))
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male & Female ≥ 70 yrs
  2. Community dwelling
  3. Short Physical Performance Battery ≤ 9
  4. Willingness to be randomized and come to the laboratory for 6 months
  5. Body Mass Index < 35
  6. Mini-Mental State Examination >=24
  7. Serum 25 (OH) D (22.5 -50 nmol/l)
  8. Having obtained his/her informed consent
  9. Able to complete 400 M walk within 15 minutes

Exclusion Criteria:

  • • Acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician

    • Current regular use (> 1 per week) of high protein oral nutritional supplements (eg: Boost, Exceed etc…)
    • Current use of Vitamin D supplements, >800 IU/day
    • Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure.
    • Upper or lower extremity fracture in previous 6 months.
    • Hemoglobin < 10 g/dL, Estimated GFR < 30 mL/min/1.73 m2
    • Uncontrolled hypertension (>150/90 mm Hg).
    • Neuromuscular diseases and drugs which affect neuromuscular function; severe progressive, degenerative neurologic disease
    • Hormone replacement therapy
    • Insulin-dependent diabetes mellitus
    • Milk protein allergy
    • Major surgery in the past 6 months (requiring general anesthesia)
    • Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia)
    • Excessive alcohol use (>14 drinks per wk)
    • Participation in moderate intensity physical activity > 20 minutes/week
    • Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
    • Severe visual impairment (if it precludes completion of assessments and/or intervention)
    • Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; wheelchair bound
    • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
    • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
    • Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
    • Patient who cannot be expected to comply with treatment, as decided by the Principal Investigator and study physician.
    • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site Principal Investigator and/or study physician.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542892

Contacts
Contact: Dylan R Kirn, B.S. 617-556-3399 Dylan.Kirn@tufts.edu
Contact: Patricia Dignon 41217858796 patricia.dignon@rdls.nestle.com

Locations
United States, Massachusetts
Jean Mayer Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Dylan R Kirn, B.S.    617-556-3399    Dylan.Kirn@tufts.edu   
Principal Investigator: Roger Fielding, Ph.D         
Sweden
Uppsala University Not yet recruiting
Uppsala, Sweden, 75185
Contact: Tommy Cederholm, MD/PhD    46186117970      
Principal Investigator: Tommy Cederholm, MD/PhD         
Sponsors and Collaborators
Tufts University
Uppsala University
Karolinska Institutet
Nestec Ltd.
Investigators
Principal Investigator: Roger Fielding, PhD Tufts University
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01542892     History of Changes
Other Study ID Numbers: 10.27.CLI
Study First Received: February 27, 2012
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
Sarcopenia
Nutrition
Vitamin D
Exercise

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014