NCT02090387

Brief Summary

The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

March 17, 2014

Last Update Submit

July 7, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Total lean body mass

    Change from baseline

    Baseline to Study Day 10

Secondary Outcomes (5)

  • Hand-grip strength

    Baseline, Study Day 10, Study Week 6 and 12

  • Short Physical Performance Battery (SPPB)

    Baseline, Study Day 10, Study Week 6 and 12

  • Isokinetic leg strength

    Baseline, Study Day 10 and Study Week 12

  • Body Mass Index (BMI)

    Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12

  • Lower extremity lean mass

    Baseline, Study Day 10, Study Weeks 6 and 12

Study Arms (2)

Control ONS

ACTIVE COMPARATOR

ONS without AN777

Other: ONS without AN777

Investigational ONS

EXPERIMENTAL

ONS containing AN777

Other: ONS containing AN777

Interventions

ONS without AN777OTHER

2 servings a day

Also known as: Commercially available ONS
Control ONS
ONS containing AN777OTHER

2 servings a day

Also known as: Investigational ONS
Investigational ONS

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 to ≤ 79 years
  • Body Mass Index (BMI) \>20 but ≤ 35 kg/m2.
  • Short Physical Performance Battery (SPPB) score of \> 9 (fully functional with no mobility limitations).
  • Triacylglyceride (TAG) level is ≤ 250 mg/dl, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 mg/dl.
  • Compliance with the various activity levels required for this study.
  • Ankle brachial index within the normal range, between 1 and 1.4.
  • Physical activity score within the 2008 Guidelines for Americans.
  • Normal-good handgrip strength.

You may not qualify if:

  • Type I or Type II Diabetes Mellitus.
  • Fasting blood glucose level of \>115 mg/dl.
  • Major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned elective surgery requiring 2 or more days of hospitalization.
  • History of pressure ulcers.
  • Stated history of Deep Vein Thrombosis (DVT), recent elevated D-dimer test, a positive ultrasound for DVT, pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or stated hypercoaguable condition, or other clotting or bleeding disorders, or is currently prescribed blood thinners.
  • Varicose veins that would result in significant discomfort while wearing TED hose and/or SCD.
  • Stated autoimmune disease or active malignant disease.
  • Estimated glomerular filtration rate is \< 50ml/min/1.73m2.
  • Current significantly impaired liver function or hepatic enzyme tests are ≥2.5 times normal limit.
  • Significant cardiovascular event ≤ 6 months prior to screening visit; or stated history of congestive heart failure.
  • Untreated hypo- or hyper-thyroidism, or other endocrinopathies associated with excessive androgen secretion.
  • Refractory anemia with hemoglobin value \<11.0 g/dl.
  • Chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV.
  • Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or has received corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months.
  • Currently being prescribed pain/anti-inflammatory medication and/or is regularly consuming over the counter pain/anti-inflammatory medication for chronic, or persistent, pain, including but not limited to arthritic conditions, fibromyalgia, and continuous localized pain.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas, 72205-7199, United States

Location

Florida Hospital Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Center of Translational Research in Aging & Longevity

College Station, Texas, 77843-4253, United States

Location

Study Officials

  • Owen Kelly, Ph.D

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

US(3)