Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Study Overview
=================
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.

Official Title
-----------------
Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Conditions
-----------------
Aged

Intervention / Treatment
-----------------
* Other: Experimental Nutritional Powder Formula
* Other: Placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AN777<br>Powder twice a day | Other: Experimental Nutritional Powder Formula<br>* Powder twice a day<br>|
| Placebo Comparator: Placebo powder<br>Powder twice a day | Other: Placebo comparator<br>* Powder twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Elderly volunteers