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CompletedNCT01542892Updated Nov 18, 2014

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

An interventional study of Exercise Intervention and Supplement Intervention in Sarcopenia, sponsored by Tufts University. Completed at 2 sites in 2 countries. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-18.

Sponsored by Tufts University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

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.

Read the 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))
02

Conditions studied

  • Sarcopenia

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Keywords

  • Sarcopenia
  • Nutrition
  • Vitamin D
  • Exercise
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 150 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Supplement

    Dietary Supplement: Supplement Intervention

  • Sham comparator
    Placebo

    Dietary Supplement: Supplement Intervention

  • Experimental
    Exercise

    Other: Exercise Intervention

Interventions

  • OtherExercise 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.

  • Dietary supplementSupplement 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.

06

What researchers measure

Primary outcomes

  1. Time to Walk 400 meters

    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.

    Time frame: 6-Month

07

Study locations

2 sites
  • Jean Mayer Human Nutrition Research Center on Aging at Tufts University
    Boston, Massachusetts 02111, United States
  • Uppsala University
    Uppsala, 75185, Sweden
08

References and documents

Publications

  • von Berens A, Fielding RA, Gustafsson T, Kirn D, Laussen J, Nydahl M, Reid K, Travison TG, Zhu H, Cederholm T, Koochek A. Effect of exercise and nutritional supplementation on health-related quality of life and mood in older adults: the VIVE2 randomized controlled trial. BMC Geriatr. 2018 Nov 21;18(1):286. doi: 10.1186/s12877-018-0976-z. PubMed 30463527 ↗
  • Englund DA, Kirn DR, Koochek A, Zhu H, Travison TG, Reid KF, von Berens A, Melin M, Cederholm T, Gustafsson T, Fielding RA. Nutritional Supplementation With Physical Activity Improves Muscle Composition in Mobility-Limited Older Adults, The VIVE2 Study: A Randomized, Double-Blind, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2017 Dec 12;73(1):95-101. doi: 10.1093/gerona/glx141. Erratum In: J Gerontol A Biol Sci Med Sci. 2019 Nov 13;74(12):1993. doi: 10.1093/gerona/glz138. PubMed 28977347 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01542892
Lead sponsor
Tufts University
Collaborators
Uppsala University, Karolinska Institutet, Nestec Ltd.
Responsible party
Sponsor
First posted
Mar 2, 2012
Start date
Oct 2011
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Nov 18, 2014

Study contacts

Roger Fielding, PhD
principal investigator · Tufts University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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