NCT00945581

Brief Summary

The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

July 23, 2009

Last Update Submit

March 28, 2011

Conditions

Aged

Keywords

Healthy Elderly volunteers

Outcome Measures

Primary Outcomes (1)

  • Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.

    10 weeks

Secondary Outcomes (4)

  • Lower extremity lean body mass

    10 weeks

  • Muscle functionality

    10 weeks

  • Total lean mass

    10 weeks

  • physical activity levels

    10 weeks

Study Arms (2)

AN777

EXPERIMENTAL

Powder twice a day

Other: Experimental Nutritional Powder Formula

Placebo powder

PLACEBO COMPARATOR

Powder twice a day

Other: Placebo comparator

Interventions

Experimental Nutritional Powder FormulaOTHER

Powder twice a day

AN777
Placebo comparatorOTHER

Powder twice a day

Placebo powder

Eligibility Criteria

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

You may qualify if:

  • Subject (male or female) is \> 60 to \< 79 years of age.
  • Subject has Body Mass Index (BMI)\> 20 \< 35.
  • Subject is ambulatory with an SPPB score of \> 9.
  • Subject agrees to comply with prescribed activity level.

You may not qualify if:

  • Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
  • Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
  • Subject has stated history of diabetes or fasting glucose value \> 126 mg/dL.
  • Subject has stated presence of partial or full artificial limb.
  • Subject has stated kidney disease or serum creatinine \> 1.4 mg/dL.
  • Subject has evidence of cardiovascular disease assessed during resting or exercise EKG.
  • Subject has untreated hypothyroidism with TSH levels greater than 5.5 microUnits/ml.
  • Subject has serum glutamate pyruvate transaminase (SGPT) levels greater than two times upper limit of laboratory-designated normal value.
  • Subject has a history of allergy to any of the ingredients in the study products.
  • Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
  • Subject has stated uncontrolled severe diarrhea, nausea or vomiting.
  • Subject is actively pursuing weight loss.
  • Subject is currently taking medications/dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, e.g. progestational agents, steroids, growth hormone, dronabinol, marijuana, beta-hydroxyl-beta-methylbutyrate (HMB), free amino acid supplements, dietary supplements to aid weight loss. Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma, topical or optical steroids and short-term use (less than two weeks) of Dexamethasone.
  • Subject cannot refrain from smoking/discontinue the use of nicotine or tobacco.
  • Subject has a stated history of Deep Vein Thrombosis (DVT) or a known hypercoaguable condition.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.

    PMID: 23514626DERIVED

Study Officials

  • Suzette Pereira, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

US(1)