Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

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.

Study Overview

• Status: Completed
• Conditions: Aged
• Intervention / Treatment: Other: Experimental Nutritional Powder Formula; Other: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Subject cannot discontinue current anticoagulant therapy.
• Subject has refractory anemia with hemoglobin value < 11.5 g/dL.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AN777; Powder twice a day	Other: Experimental Nutritional Powder Formula; Powder twice a day
Placebo Comparator: Placebo powder; Powder twice a day	Other: Placebo comparator; Powder twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Lower extremity lean body mass	10 weeks
Muscle functionality	10 weeks
Total lean mass	10 weeks
physical activity levels	10 weeks

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Suzette Pereira, PhD, Abbott Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Healthy Elderly volunteers
• Other Study ID Numbers: BK37