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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Supplement Intervention; Other: Exercise Intervention

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))

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Karolinska Institutet; Uppsala University; Nestec Ltd.
• Investigators: Principal Investigator: Roger Fielding, PhD, Tufts University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (ESTIMATE): March 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; Vitamin D; Nutrition; Sarcopenia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 10.27.CLI