Evaluation of AN777 in Elderly Subjects

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

Study Overview

• Status: Completed
• Conditions: Aged
• Intervention / Treatment: Other: Ad lib diet and Control placebo; Other: Ad lib diet and An 777; Other: Ad lib diet/ placebo/ exercise; Other: Ad lib diet; AN 777; exercise

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Norman, Oklahoma, United States, 73019
      • Department of Health and Exercise Science, University of Oklahoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
2. Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
3. Subject has stated immunodeficiency disorder
4. Subject has stated history of diabetes
5. Subject has stated presence of partial or full artificial limb
6. Subject has stated kidney disease
7. Subject has stated history of uncontrollable hypertension
8. Subject had myocardial infarction within the last 3 months
9. Subject had recent antibiotic use (within 1 week prior to screening).
10. Subject has a history of allergy to any of the ingredients in the study products
11. 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
12. Subject has stated uncontrolled severe diarrhea, nausea or vomiting
13. Subject has untreated clinically significant ascites, pleural effusion or edema
14. 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
15. Subject is actively pursuing weight loss
16. Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ad lib diet/placebo; Ad lib diet and control product placebo	Other: Ad lib diet and Control placebo; one packet with water two times a day
Experimental: Ad lib diet/AN 777; Ad lib diet and AN 777	Other: Ad lib diet and An 777; one packet with water two times a day
Active Comparator: Ad lib diet/placebo/exercise; Diet ad lib; exercise; and placebo	Other: Ad lib diet/ placebo/ exercise; one packet with water two times a day; resistance training three times a week
Experimental: Ad lib diet/ AN 777/ exercise; Diet ad lib; AN 777; exercise	Other: Ad lib diet; AN 777; exercise; one packet with water two times a day; resistance training three times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.	24 weeks

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Catherine Johnson, PhD, Abbott Nutrition

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): March 22, 2010
• Last Update Submitted That Met QC Criteria: March 19, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: BK32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No