Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AN777

Powder twice a day

Group Type EXPERIMENTAL

Experimental Nutritional Powder Formula

Intervention Type OTHER

Powder twice a day

Placebo powder

Powder twice a day

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

Powder twice a day

Interventions

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Experimental Nutritional Powder Formula

Powder twice a day

Intervention Type OTHER

Placebo comparator

Powder twice a day

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes