NCT00798291

Brief Summary

To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 22, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

November 25, 2008

Last Update Submit

March 19, 2010

Conditions

Aged

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.

    24 weeks

Secondary Outcomes (1)

  • The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.

    24 weeks

Study Arms (4)

Ad lib diet/placebo

PLACEBO COMPARATOR

Ad lib diet and control product placebo

Other: Ad lib diet and Control placebo

Ad lib diet/AN 777

EXPERIMENTAL

Ad lib diet and AN 777

Other: Ad lib diet and An 777

Ad lib diet/placebo/exercise

ACTIVE COMPARATOR

Diet ad lib; exercise; and placebo

Other: Ad lib diet/ placebo/ exercise

Ad lib diet/ AN 777/ exercise

EXPERIMENTAL

Diet ad lib; AN 777; exercise

Other: Ad lib diet; AN 777; exercise

Interventions

Ad lib diet and Control placeboOTHER

one packet with water two times a day

Ad lib diet/placebo
Ad lib diet and An 777OTHER

one packet with water two times a day

Ad lib diet/AN 777
Ad lib diet/ placebo/ exerciseOTHER

one packet with water two times a day; resistance training three times a week

Ad lib diet/placebo/exercise
Ad lib diet; AN 777; exerciseOTHER

one packet with water two times a day; resistance training three times a week

Ad lib diet/ AN 777/ exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subject (male or female) is at least 65 years of age
  • Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over
  • Subject has Body Mass Index (BMI) \> 20.0 but \<30.0
  • Subject is ambulatory
  • Subject agrees to maintain current activity level

You may not qualify if:

  • Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
  • Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
  • Subject has stated immunodeficiency disorder
  • Subject has stated history of diabetes
  • Subject has stated presence of partial or full artificial limb
  • Subject has stated kidney disease
  • Subject has stated history of uncontrollable hypertension
  • Subject had myocardial infarction within the last 3 months
  • Subject had recent antibiotic use (within 1 week prior to screening).
  • 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
  • Subject has stated uncontrolled severe diarrhea, nausea or vomiting
  • Subject has untreated clinically significant ascites, pleural effusion or edema
  • Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption
  • Subject is actively pursuing weight loss
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health and Exercise Science, University of Oklahoma

Norman, Oklahoma, 73019, United States

Location

Related Publications (2)

  • Fukuda DH, Stout JR, Moon JR, Smith-Ryan AE, Kendall KL, Hoffman JR. Effects of resistance training on classic and specific bioelectrical impedance vector analysis in elderly women. Exp Gerontol. 2016 Feb;74:9-12. doi: 10.1016/j.exger.2015.12.002. Epub 2015 Dec 2.

    PMID: 26657810DERIVED

  • Stout JR, Fukuda DH, Kendall KL, Smith-Ryan AE, Moon JR, Hoffman JR. beta-Hydroxy-beta-methylbutyrate (HMB) supplementation and resistance exercise significantly reduce abdominal adiposity in healthy elderly men. Exp Gerontol. 2015 Apr;64:33-4. doi: 10.1016/j.exger.2015.02.012. Epub 2015 Feb 17.

    PMID: 25700845DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Catherine Johnson, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 26, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

March 22, 2010

Record last verified: 2010-03

Locations

US(1)