ElderlyPhase 3NCT01483976
Comparison of Medical Nutritional Supplements
A Phase 3 study testing Oral medical nutritional supplement and Experimental oral medical nutritional supplement with AN777 in people with Elderly, run by Abbott Nutrition at 1 site in United States.
Trial summary
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Oral medical nutritional supplement and Experimental oral medical nutritional supplement with AN777
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and is ≥ 60 and ≤ 90 years of age.
- Body Mass Index (BMI) > 20.0, but < 35.0.
- Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
- Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
- Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
- Refrain from intense physical activity between visits.
Who cannot join
- Systemic corticosteroids within the 3 months prior to enrollment.
- Blood thinner or anticoagulant medication within 1 week prior to enrollment.
- Glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2.
- Antibiotics within 1 week prior to enrollment.
- Major surgery less than 3 months prior to enrollment in the study.
- Active malignant disease or treated within the last 6 months for cancer.
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- Immunodeficiency disorder.
- Diabetes
- Myocardial infarction 3 months prior to enrollment.
- Chronic obstructive pulmonary disease
- History of allergy to any of the ingredients in the study products.
- Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
- Pursuing weight loss or weight gain.
- Medications/dietary supplements/substances that could modulate metabolism or weight.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
- Conditions
- Elderly
- Being tested
- Oral medical nutritional supplement, Experimental oral medical nutritional supplement with AN777
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral medical nutritional supplementOther
orally over a three hour period
Experimental oral medical nutritional supplement with AN777Other
orally over a three hour period
| Study group | Role | What they receive |
|---|---|---|
| Oral medical nutritional supplement without AN777 | Active comparator | orally over a three hour period Receives: Other: Oral medical nutritional supplement |
| Experimental oral medical nutritional supplement with AN777 | Experimental | orally over a three hour period Receives: Other: Experimental oral medical nutritional supplement with AN777 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protein metabolism
Via amino acid tracers
Measured: Between baseline and 8 hours later
Secondary outcomes (1)
Intracellular signaling pathway metabolism
Via Amino acid tracers and protein phosphorylation measurements
Measured: Between Baseline and 8 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikkie Mustad, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483976
- Sponsor's protocol ID
- BK96
- Status last verified
- Jan 2013
- First submitted
- 23 Nov 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
- ClinicalTrials.gov ID
- NCT01483976
- Acronym / sponsor ID
- BK96
- Conditions
- Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral medical nutritional supplement without AN777 | Active comparator | Other: Oral medical nutritional supplementorally over a three hour period |
| Experimental oral medical nutritional supplement with AN777 | Experimental | Other: Experimental oral medical nutritional supplement with AN777orally over a three hour period |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and is ≥ 60 and ≤ 90 years of age.
- Body Mass Index (BMI) > 20.0, but < 35.0.
- Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
- Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
- Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
Key exclusion criteria (15 listed)
- Systemic corticosteroids within the 3 months prior to enrollment.
- Blood thinner or anticoagulant medication within 1 week prior to enrollment.
- Glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2.
- Antibiotics within 1 week prior to enrollment.
- Major surgery less than 3 months prior to enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral medical nutritional supplementorally over a three hour period | Other | Oral medical nutritional supplement without AN777 |
| Experimental oral medical nutritional supplement with AN777orally over a three hour period | Other | Experimental oral medical nutritional supplement with AN777 |
Primary outcome
Change in protein metabolism
Time frame: Between baseline and 8 hours later
Via amino acid tracers
1 secondary outcome
Intracellular signaling pathway metabolism
Time frame: Between Baseline and 8 hours later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikkie Mustad, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral medical nutritional supplement and Experimental oral medical nutritional supplement with AN777 in people with Elderly, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in protein metabolism (time frame: Between baseline and 8 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.