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. (see Contacts and Locations)
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
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: 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 July 22, 2014