Evaluation of an Oral Nutritional Supplement Containing AN777
NCT ID: NCT01191125
Last Updated: 2013-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2011-02-28
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics Evaluation of Vitamin D Formulations
NCT05209425
Inter-relationship Between Vitamin D Requirements and Calcium Intake in Older Adults
NCT01990872
Efficacy of Oral Vitamin D Supplementation in Adolescents and Young Adults.
NCT04377386
Vitamin D Supplementation and Muscle Function in Older Adults
NCT02015611
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
NCT04935034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
medical food with AN777
medical food with AN777
Two(220 mL)servings every day for six months
oral nutritional formula
oral nutritional formula
Two (220 mL) servings daily for six months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
medical food with AN777
Two(220 mL)servings every day for six months
oral nutritional formula
Two (220 mL) servings daily for six months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Subject is ambulatory
Subject has a Subjective Global Assessment of B or C
Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength
Subject has Class 1 or Class 2 sarcopenia
Subject agrees to refrain from starting a resistance exercise program
Exclusion Criteria
Subject has inflammatory disease with elevated high sensitivity C-reactive protein
Subject has renal function impairment
Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease
Subject reports of current active malignant disease or other significant medical diagnoses.
Subject reports a history of allergy to any of the ingredients in the study products
Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.
65 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vikkie Mustad, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama, Brimingham
Birmington, Alabama, United States
Radiant Research, Inc
Santa Rosa, California, United States
Provident Clinical Research
Addison, Illinois, United States
Radiant Research, Inc
Chicago, Illinois, United States
Radiant Research, Inc.
Overland Park, Kansas, United States
Creighton University
Omaha, Nebraska, United States
Radiant Research, Inc
Cincinnati, Ohio, United States
Radiant Research, Inc.
Dallas, Texas, United States
ZNA St. Elisabeth
Antwerp, , Belgium
Catholic University of Rome
Rome, , Italy
University of Verona
Verona, , Italy
Althian - Research Management Center
Monterrey, Nuevo León, Mexico
NSZOZ Unica CR
Dąbrówka, , Poland
Mazowieckie Centrum Badan Klinicznych S.C..
Grodzisk Mazowiecki, , Poland
Tomasz Dabrowski Slaskie Centrum
Katowice, , Poland
Centrum Medyczne Osteomed
Warsaw, , Poland
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Insituto Provincial de Rehabilitacion
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
University Hospitals, WHO
Geneva, , Switzerland
Imperial College Healthcare NHS Trust
Charing Cross, London, United Kingdom
University of Nottingham Medical School,
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cramer JT, Cruz-Jentoft AJ, Landi F, Hickson M, Zamboni M, Pereira SL, Hustead DS, Mustad VA. Impacts of High-Protein Oral Nutritional Supplements Among Malnourished Men and Women with Sarcopenia: A Multicenter, Randomized, Double-Blinded, Controlled Trial. J Am Med Dir Assoc. 2016 Nov 1;17(11):1044-1055. doi: 10.1016/j.jamda.2016.08.009.
Hickson M. Nutritional interventions in sarcopenia: a critical review. Proc Nutr Soc. 2015 Nov;74(4):378-86. doi: 10.1017/S0029665115002049. Epub 2015 Apr 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BK94
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.