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OpenTrials
Completed

NCT Number: NCT00798291

Evaluation of AN777 in Elderly Subjects

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

Completed

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Health and Exercise Science, University of Oklahoma

Norman, Oklahoma, 73019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ad lib diet and Control placebo

Other

one packet with water two times a day

Ad lib diet and An 777

Other

one packet with water two times a day

Ad lib diet/ placebo/ exercise

Other

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

Ad lib diet; AN 777; exercise

Other

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

Primary outcomes

  1. The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.

    Time frame: 24 weeks

Secondary outcomes

  1. The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 26, 2008
Registry last updated
Mar 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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