AgedPhase 1/2NCT00945581
Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
A Phase 1/2 study testing Experimental Nutritional Powder Formula in people with Aged, run by Abbott Nutrition at 1 site in United States.
Trial summary
The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- Experimental Nutritional Powder Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 1/2
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject (male or female) is > 60 to < 79 years of age.
- Subject has Body Mass Index (BMI)> 20 < 35.
- Subject is ambulatory with an SPPB score of > 9.
- Subject agrees to comply with prescribed activity level.
Who cannot join
- Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
- Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- Subject has stated history of diabetes or fasting glucose value > 126 mg/dL.
- Subject has stated presence of partial or full artificial limb.
- Subject has stated kidney disease or serum creatinine > 1.4 mg/dL.
- Subject has evidence of cardiovascular disease assessed during resting or exercise EKG.
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- Subject has untreated hypothyroidism with TSH levels greater than 5.5 microUnits/ml.
- Subject has serum glutamate pyruvate transaminase (SGPT) levels greater than two times upper limit of laboratory-designated normal value.
- 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 such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
- Subject has stated uncontrolled severe diarrhea, nausea or vomiting.
- Subject is actively pursuing weight loss.
- Subject is currently taking medications/dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, e.g. progestational agents, steroids, growth hormone, dronabinol, marijuana, beta-hydroxyl-beta-methylbutyrate (HMB), free amino acid supplements, dietary supplements to aid weight loss. Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma, topical or optical steroids and short-term use (less than two weeks) of Dexamethasone.
- Subject cannot refrain from smoking/discontinue the use of nicotine or tobacco.
- Subject has a stated history of Deep Vein Thrombosis (DVT) or a known hypercoaguable condition.
- Subject cannot discontinue current anticoagulant therapy.
- Subject has refractory anemia with hemoglobin value < 11.5 g/dL.
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
The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.
- Conditions
- Aged
- Being tested
- Experimental Nutritional Powder Formula, Placebo comparator
- Keywords
- Healthy Elderly volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Nutritional Powder FormulaOther
Powder twice a day
Placebo comparatorOther
Powder twice a day
| Study group | Role | What they receive |
|---|---|---|
| AN777 | Experimental | Powder twice a day Receives: Other: Experimental Nutritional Powder Formula |
| Placebo powder | Placebo comparator | Powder twice a day Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.
Measured: 10 weeks
Secondary outcomes (4)
Lower extremity lean body mass
Measured: 10 weeks
Muscle functionality
Measured: 10 weeks
Total lean mass
Measured: 10 weeks
physical activity levels
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Suzette Pereira, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945581
- Sponsor's protocol ID
- BK37
- Status last verified
- Mar 2011
- First submitted
- 23 Jul 2009
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
PubMed 23514626
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
- ClinicalTrials.gov ID
- NCT00945581
- Acronym / sponsor ID
- BK37
- Conditions
- Aged
- Keywords
- Healthy Elderly volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Jul 2009 (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 primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AN777 | Experimental | Other: Experimental Nutritional Powder FormulaPowder twice a day |
| Placebo powder | Placebo comparator | Other: Placebo comparatorPowder twice a day |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject (male or female) is > 60 to < 79 years of age.
- Subject has Body Mass Index (BMI)> 20 < 35.
- Subject is ambulatory with an SPPB score of > 9.
- Subject agrees to comply with prescribed activity level.
Key exclusion criteria (17 listed)
- Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
- Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- Subject has stated history of diabetes or fasting glucose value > 126 mg/dL.
- Subject has stated presence of partial or full artificial limb.
- Subject has stated kidney disease or serum creatinine > 1.4 mg/dL.
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 |
|---|---|---|
| Experimental Nutritional Powder FormulaPowder twice a day | Other | AN777 |
| Placebo comparatorPowder twice a day | Other | Placebo powder |
Primary outcome
Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.
Time frame: 10 weeks
4 secondary outcomes
Lower extremity lean body mass
Time frame: 10 weeks
Muscle functionality
Time frame: 10 weeks
Total lean mass
Time frame: 10 weeks
physical activity levels
Time frame: 10 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 29 Mar 2011.
- Derived from this study: PubMed 23514626Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
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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.
Suzette Pereira, 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 1/2 study testing Experimental Nutritional Powder Formula 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 4 inclusion and 17 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 29 Mar 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period. (time frame: 10 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 NCT00945581, which also lists 1 linked publication.
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 29 Mar 2011.