Evaluation of AN777 in Elderly Subjects

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

PHASE2/PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-01-31

Brief Summary

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

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ad lib diet/placebo

Ad lib diet and control product placebo

Group Type PLACEBO_COMPARATOR

Ad lib diet and Control placebo

Intervention Type OTHER

one packet with water two times a day

Ad lib diet/AN 777

Ad lib diet and AN 777

Group Type EXPERIMENTAL

Ad lib diet and An 777

Intervention Type OTHER

one packet with water two times a day

Ad lib diet/placebo/exercise

Diet ad lib; exercise; and placebo

Group Type ACTIVE_COMPARATOR

Ad lib diet/ placebo/ exercise

Intervention Type OTHER

one packet with water two times a day; resistance training three times a week

Ad lib diet/ AN 777/ exercise

Diet ad lib; AN 777; exercise

Group Type EXPERIMENTAL

Ad lib diet; AN 777; exercise

Intervention Type OTHER

one packet with water two times a day; resistance training three times a week

Interventions

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Ad lib diet and Control placebo

one packet with water two times a day

Intervention Type OTHER

Ad lib diet and An 777

one packet with water two times a day

Intervention Type OTHER

Ad lib diet/ placebo/ exercise

one packet with water two times a day; resistance training three times a week

Intervention Type OTHER

Ad lib diet; AN 777; exercise

one packet with water two times a day; resistance training three times a week

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes