HealthyNCT02090387
Evaluation of an Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects.
A study testing ONS without AN777 and ONS containing AN777 in people with Healthy, run by Abbott Nutrition at 3 sites in United States.
Trial summary
The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ONS without AN777 and ONS containing AN777
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2014to Apr 2016
- Phase
- Interventional
- 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
- Age ≥ 60 to ≤ 79 years
- Body Mass Index (BMI) >20 but ≤ 35 kg/m2.
- Short Physical Performance Battery (SPPB) score of > 9 (fully functional with no mobility limitations).
- Triacylglyceride (TAG) level is ≤ 250 mg/dl, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 mg/dl.
- Compliance with the various activity levels required for this study.
- Ankle brachial index within the normal range, between 1 and 1.4.
- Physical activity score within the 2008 Guidelines for Americans.
- Normal-good handgrip strength.
Who cannot join
- Type I or Type II Diabetes Mellitus.
- Fasting blood glucose level of >115 mg/dl.
- Major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned elective surgery requiring 2 or more days of hospitalization.
- History of pressure ulcers.
- Stated history of Deep Vein Thrombosis (DVT), recent elevated D-dimer test, a positive ultrasound for DVT, pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or stated hypercoaguable condition, or other clotting or bleeding disorders, or is currently prescribed blood thinners.
- Varicose veins that would result in significant discomfort while wearing TED hose and/or SCD.
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- Stated autoimmune disease or active malignant disease.
- Estimated glomerular filtration rate is < 50ml/min/1.73m2.
- Current significantly impaired liver function or hepatic enzyme tests are ≥2.5 times normal limit.
- Significant cardiovascular event ≤ 6 months prior to screening visit; or stated history of congestive heart failure.
- Untreated hypo- or hyper-thyroidism, or other endocrinopathies associated with excessive androgen secretion.
- Refractory anemia with hemoglobin value <11.0 g/dl.
- Chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV.
- Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or has received corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months.
- Currently being prescribed pain/anti-inflammatory medication and/or is regularly consuming over the counter pain/anti-inflammatory medication for chronic, or persistent, pain, including but not limited to arthritic conditions, fibromyalgia, and continuous localized pain.
- History of allergy to any of the ingredients in the study products.
- Deleted
- Obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease.
- Stated uncontrolled severe diarrhea, nausea or vomiting.
- Amputee.
- Actively pursuing weight loss or gain.
- Cannot refrain from taking medications/dietary supplements (all forms)/substances that could modulate metabolism or body weight.
- Cannot refrain from taking long chain n-3 polyunsaturated fatty acids (PUFA) (eicosapentaenoic acid (EPA) ± docosahexaenoic acid (DHA) ± α-linolenic acid (ALA)), or vitamin D, at levels that are significantly higher than the established Acceptable Macronutrient Distribution Range (AMDR), or recommended by the American Heart Association (500 mg/d total EPA+DHA), during the study.
- Cannot refrain from smoking or discontinue the use of nicotine (all forms including patches) or tobacco during the study.
- One or more metal implants.
- Currently diagnosis or a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance.
- Cannot abstain from alcohol use during the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center of Translational Research in Aging & Longevity
College Station, Texas, 77843-4253
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205-7199
Florida Hospital Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.
The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.
- Conditions
- Healthy
- Being tested
- ONS without AN777, ONS containing AN777
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS without AN777Other
Also called Commercially available ONS
2 servings a day
ONS containing AN777Other
Also called Investigational ONS
2 servings a day
| Study group | Role | What they receive |
|---|---|---|
| Control ONS | Active comparator | ONS without AN777 Receives: Other: ONS without AN777 |
| Investigational ONS | Experimental | ONS containing AN777 Receives: Other: ONS containing AN777 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total lean body mass
Change from baseline
Measured: Baseline to Study Day 10
Secondary outcomes (5)
Hand-grip strength
Change from baseline
Measured: Baseline, Study Day 10, Study Week 6 and 12
Short Physical Performance Battery (SPPB)
Change from baseline
Measured: Baseline, Study Day 10, Study Week 6 and 12
Isokinetic leg strength
Change from baseline
Measured: Baseline, Study Day 10 and Study Week 12
Body Mass Index (BMI)
Calculated BMI = weight/height2 (kg/m2).
Measured: Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12
Lower extremity lean mass
Measured by DXA; Change from baseline
Measured: Baseline, Study Day 10, Study Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Owen Kelly, Ph.D, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090387
- Sponsor's protocol ID
- BL20
- Status last verified
- Jul 2016
- First submitted
- 17 Mar 2014
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.
- ClinicalTrials.gov ID
- NCT02090387
- Acronym / sponsor ID
- BL20
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Mar 2014 (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 study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control ONS | Active comparator | Other: ONS without AN777ONS without AN777 |
| Investigational ONS | Experimental | Other: ONS containing AN777ONS containing AN777 |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 60 to ≤ 79 years
- Body Mass Index (BMI) >20 but ≤ 35 kg/m2.
- Short Physical Performance Battery (SPPB) score of > 9 (fully functional with no mobility limitations).
- Triacylglyceride (TAG) level is ≤ 250 mg/dl, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 mg/dl.
- Compliance with the various activity levels required for this study.
Key exclusion criteria (27 listed)
- Type I or Type II Diabetes Mellitus.
- Fasting blood glucose level of >115 mg/dl.
- Major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned elective surgery requiring 2 or more days of hospitalization.
- History of pressure ulcers.
- Stated history of Deep Vein Thrombosis (DVT), recent elevated D-dimer test, a positive ultrasound for DVT, pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or stated hypercoaguable condition, or other clotting or bleeding disorders, or is currently prescribed blood thinners.
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 |
|---|---|---|
| ONS without AN777Also: Commercially available ONS2 servings a day | Other | Control ONS |
| ONS containing AN777Also: Investigational ONS2 servings a day | Other | Investigational ONS |
Primary outcome
Total lean body mass
Time frame: Baseline to Study Day 10
Change from baseline
5 secondary outcomes
Hand-grip strength
Time frame: Baseline, Study Day 10, Study Week 6 and 12
Short Physical Performance Battery (SPPB)
Time frame: Baseline, Study Day 10, Study Week 6 and 12
Isokinetic leg strength
Time frame: Baseline, Study Day 10 and Study Week 12
Body Mass Index (BMI)
Time frame: Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12
Lower extremity lean mass
Time frame: Baseline, Study Day 10, Study Weeks 6 and 12
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 11 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Owen Kelly, Ph.D study chair
Abbott Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS without AN777 and ONS containing AN777 in people with Healthy, run by Abbott Nutrition at 3 sites 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 8 inclusion and 27 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Total lean body mass (time frame: Baseline to Study Day 10). 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 11 Jul 2016.