MalnutritionPhase 3NCT01191125
Evaluation of an Oral Nutritional Supplement Containing AN777
A Phase 3 study testing medical food with AN777 and oral nutritional formula in people with Malnutrition and Sarcopenia, run by Abbott Nutrition at 23 sites in 8 countries.
Trial summary
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Malnutrition, Sarcopenia
- What is being tested?
- medical food with AN777 and oral nutritional formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Feb 2011to Sep 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject (male or female) is > or equal to 65 and < or equal to 90 years of age
- 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
Who cannot join
- Subject has type 1 or type 2 diabetes
- 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.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States8 sites
Provident Clinical Research
Addison, Illinois, 60101
University of Alabama, Brimingham
Birmington, Alabama, 35294
Radiant Research, Inc
Chicago, Illinois, 60654
Radiant Research, Inc
Cincinnati, Ohio, 45249
Radiant Research, Inc.
Dallas, Texas, 75231
Creighton University
Omaha, Nebraska, 68178
Radiant Research, Inc.
Overland Park, Kansas, 66202
Radiant Research, Inc
Santa Rosa, California, 95405
Poland4 sites
NSZOZ Unica CR
Dąbrówka, 62-069
Mazowieckie Centrum Badan Klinicznych S.C..
Grodzisk Mazowiecki, 05-825
Tomasz Dabrowski Slaskie Centrum
Katowice, 40-084
Centrum Medyczne Osteomed
Warsaw, 02-241
Spain4 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Insituto Provincial de Rehabilitacion
Madrid, 28028
Hospital Universitario Ramon y Cajal
Madrid, 28034
Italy2 sites
Catholic University of Rome
Rome, 00168
University of Verona
Verona, 37126
United Kingdom2 sites
Imperial College Healthcare NHS Trust
Charing Cross, London, W6 8RF
University of Nottingham Medical School,
Nottingham, NG7 2UH
About this study
Official title: Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
- Conditions
- Malnutrition, Sarcopenia
- Being tested
- medical food with AN777, oral nutritional formula
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical food with AN777Other
Two(220 mL)servings every day for six months
oral nutritional formulaOther
Two (220 mL) servings daily for six months
| Study group | Role | What they receive |
|---|---|---|
| medical food with AN777 | Experimental | Not described Receives: Other: medical food with AN777 |
| oral nutritional formula | Active comparator | Not described Receives: Other: oral nutritional formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensor strength
Measured: Six months
Secondary outcomes (3)
Leg muscle mass
Measured: Six months
Body Weight
Measured: Six months
Functional measures
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 331 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
- NCT01191125
- Sponsor's protocol ID
- BK94
- Status last verified
- Mar 2013
- First submitted
- 27 Aug 2010
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27780567Hickson 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.
PubMed 25923603
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects
- ClinicalTrials.gov ID
- NCT01191125
- Acronym / sponsor ID
- BK94
- Conditions
- Malnutrition, Sarcopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2010 (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.
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical food with AN777 | Experimental | Other: medical food with AN777 |
| oral nutritional formula | Active comparator | Other: oral nutritional formula |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Subject (male or female) is > or equal to 65 and < or equal to 90 years of age
- 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
Key exclusion criteria (7 listed)
- Subject has type 1 or type 2 diabetes
- 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.
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 |
|---|---|---|
| medical food with AN777Two(220 mL)servings every day for six months | Other | medical food with AN777 |
| oral nutritional formulaTwo (220 mL) servings daily for six months | Other | oral nutritional formula |
Primary outcome
Knee extensor strength
Time frame: Six months
3 secondary outcomes
Leg muscle mass
Time frame: Six months
Body Weight
Time frame: Six months
Functional measures
Time frame: Six months
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 7 Mar 2013.
- Derived from this study: PubMed 27780567Cramer 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.
- Derived from this study: PubMed 25923603Hickson 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.
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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
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing medical food with AN777 and oral nutritional formula in people with Malnutrition and Sarcopenia, run by Abbott Nutrition at 23 sites in 8 countries.
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 7 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 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Poland, Spain, Italy, United Kingdom and 3 more countries. 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?
Knee extensor strength (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01191125, which also lists 2 linked publications.
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 7 Mar 2013.