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

NCT01542892 | Completed

• 1 other identifier: 10.27.CLI
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Nutrition; Vitamin D; Exercise

Outcome Measures

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.

  6-Month

Study Arms (3)

Supplement

EXPERIMENTAL

Dietary Supplement: Supplement Intervention

Placebo

SHAM COMPARATOR

Dietary Supplement: Supplement Intervention

Exercise

EXPERIMENTAL

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

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.

Exercise

Supplement Intervention DIETARY_SUPPLEMENT

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

Placebo; Supplement

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Uppsala University: collaborator
• Karolinska Institutet: collaborator
• Nestec Ltd.: collaborator

Study Sites (2)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Uppsala University

Uppsala, 75185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 30463527 DERIVED

• 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.

  PMID: 28977347 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Roger Fielding, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: October 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

SE (1); US (1)