AgedPhase 2/3NCT00798291
Evaluation of AN777 in Elderly Subjects
A Phase 2/3 study testing Ad lib diet and An 777 and Ad lib diet; AN 777; exercise in people with Aged, run by Abbott Nutrition at 1 site in United States.
Trial summary
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Ad lib diet and An 777 and Ad lib diet; AN 777; exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2010
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science, University of Oklahoma
Norman, Oklahoma, 73019
About this study
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
- Conditions
- Aged
- Being tested
- Ad lib diet and Control placebo, Ad lib diet and An 777, Ad lib diet/ placebo/ exercise, Ad lib diet; AN 777; exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad lib diet and Control placeboOther
one packet with water two times a day
Ad lib diet and An 777Other
one packet with water two times a day
Ad lib diet/ placebo/ exerciseOther
one packet with water two times a day; resistance training three times a week
Ad lib diet; AN 777; exerciseOther
one packet with water two times a day; resistance training three times a week
| Study group | Role | What they receive |
|---|---|---|
| Ad lib diet/placebo | Placebo comparator | Ad lib diet and control product placebo Receives: Other: Ad lib diet and Control placebo |
| Ad lib diet/AN 777 | Experimental | Ad lib diet and AN 777 Receives: Other: Ad lib diet and An 777 |
| Ad lib diet/placebo/exercise | Active comparator | Diet ad lib; exercise; and placebo Receives: Other: Ad lib diet/ placebo/ exercise |
| Ad lib diet/ AN 777/ exercise | Experimental | Diet ad lib; AN 777; exercise Receives: Other: Ad lib diet; AN 777; exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionJan 2010
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 AgedStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Johnson, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798291
- Sponsor's protocol ID
- BK32
- Status last verified
- Mar 2010
- First submitted
- 25 Nov 2008
- Last updated
- 22 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fukuda DH, Stout JR, Moon JR, Smith-Ryan AE, Kendall KL, Hoffman JR. Effects of resistance training on classic and specific bioelectrical impedance vector analysis in elderly women. Exp Gerontol. 2016 Feb;74:9-12. doi: 10.1016/j.exger.2015.12.002. Epub 2015 Dec 2.
PubMed 26657810Stout JR, Fukuda DH, Kendall KL, Smith-Ryan AE, Moon JR, Hoffman JR. beta-Hydroxy-beta-methylbutyrate (HMB) supplementation and resistance exercise significantly reduce abdominal adiposity in healthy elderly men. Exp Gerontol. 2015 Apr;64:33-4. doi: 10.1016/j.exger.2015.02.012. Epub 2015 Feb 17.
PubMed 25700845
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AN777 in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00798291
- Acronym / sponsor ID
- BK32
- Conditions
- Aged
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Nov 2008 (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 whether AN777 with or without exercise affects muscle mass change in elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ad lib diet/placebo | Placebo comparator | Other: Ad lib diet and Control placeboAd lib diet and control product placebo |
| Ad lib diet/AN 777 | Experimental | Other: Ad lib diet and An 777Ad lib diet and AN 777 |
| Ad lib diet/placebo/exercise | Active comparator | Other: Ad lib diet/ placebo/ exerciseDiet ad lib; exercise; and placebo |
| Ad lib diet/ AN 777/ exercise | Experimental | Other: Ad lib diet; AN 777; exerciseDiet ad lib; AN 777; exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Ad lib diet and Control placeboone packet with water two times a day | Other | Ad lib diet/placebo |
| Ad lib diet and An 777one packet with water two times a day | Other | Ad lib diet/AN 777 |
| Ad lib diet/ placebo/ exerciseone packet with water two times a day; resistance training three times a week | Other | Ad lib diet/placebo/exercise |
| Ad lib diet; AN 777; exerciseone packet with water two times a day; resistance training three times a week | Other | Ad lib diet/ AN 777/ exercise |
Primary outcome
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
1 secondary outcome
The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.
Time frame: 24 weeks
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 22 Mar 2010.
- Derived from this study: PubMed 26657810Fukuda DH, Stout JR, Moon JR, Smith-Ryan AE, Kendall KL, Hoffman JR. Effects of resistance training on classic and specific bioelectrical impedance vector analysis in elderly women. Exp Gerontol. 2016 Feb;74:9-12. doi: 10.1016/j.exger.2015.12.002. Epub 2015 Dec 2.
- Derived from this study: PubMed 25700845Stout JR, Fukuda DH, Kendall KL, Smith-Ryan AE, Moon JR, Hoffman JR. beta-Hydroxy-beta-methylbutyrate (HMB) supplementation and resistance exercise significantly reduce abdominal adiposity in healthy elderly men. Exp Gerontol. 2015 Apr;64:33-4. doi: 10.1016/j.exger.2015.02.012. Epub 2015 Feb 17.
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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.
Catherine Johnson, 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 2/3 study testing Ad lib diet and An 777 and Ad lib diet; AN 777; exercise in people with Aged, 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 5 inclusion and 16 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 22 Mar 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). 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 NCT00798291, 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 22 Mar 2010.