Evaluation of AN777 in Elderly Subjects

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

Official Title
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Evaluation of AN777 in Elderly Subjects

Conditions
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Aged

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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