MalnutritionNCT02052232
Study of Protein Metabolism in Healthy Older Subjects
A study testing Experimental protein powder sachet in people with Malnutrition, run by Abbott Nutrition at 1 site in United Kingdom.
Trial summary
This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Experimental protein powder sachet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Apr 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 and ≤ 75 years
- Body Mass Index (BMI) > 23.0 to < 30.0
- Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance
- Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.
Who cannot join
- Diagnosis of diabetes
- Active pursuit of weight loss
- Poorly controlled hypertension or hypotension
- Untreated hypothyroidism or hyperthyroidism
- Anemia or abnormally functioning kidneys or liver
- A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG
Show all 23Show fewer
- Peripheral arterial disease or other diseases that preclude proper limb blood flow
- Chronic, contagious, infectious disease
- Current infection or corticosteroid treatment within the last 3 months
- Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition
- In condition deemed unsuitable for study based upon study physician assessment
- Surgery requiring >2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring >2 days of hospitalization during the course of the study
- Current active malignant disease or was treated within the last 6 months for cancer
- An amputee
- Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
- Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
- Cannot refrain from taking
- High doses of fish oil, or omega-3 supplements, or high doses of vitamin D
- Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight
- Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2
- NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2
- Chronic use of nicotine
- Allergic or intolerant to any ingredient found in the study products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Acute Muscle Protein Metabolism in Healthy Older Subjects
This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.
- Conditions
- Malnutrition
- Being tested
- Experimental protein powder sachet, Control protein powder sachet
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental protein powder sachetOther
mixed with 8 oz. water
Control protein powder sachetOther
mixed with 8 oz. water
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control protein powder sachet Receives: Other: Control protein powder sachet |
| Experimental | Experimental | Experimental protein powder sachet Receives: Other: Experimental protein powder sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Metabolism
Study Visit 1 and Study Visit 2
Measured: Change from - 1 to + 5 hours
Secondary outcomes (3)
Macrovascular Blood Flow
Study Visit 1 and Study Visit 2
Measured: Change from -1 to +5 hours
Glycemic Markers
Study Visit 1 and Study Visit 2
Measured: Change from -1 to +5 hours
Microvascular Blood Flow
Study Visit 1 and Study Visit 2
Measured: Change from -1 to +5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Tian, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052232
- Sponsor's protocol ID
- BL19
- Status last verified
- Jun 2016
- First submitted
- 6 Dec 2013
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acute Muscle Protein Metabolism in Healthy Older Subjects
- ClinicalTrials.gov ID
- NCT02052232
- Acronym / sponsor ID
- BL19
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Feb 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.
This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control protein powder sachetControl protein powder sachet |
| Experimental | Experimental | Other: Experimental protein powder sachetExperimental protein powder sachet |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60 and ≤ 75 years
- Body Mass Index (BMI) > 23.0 to < 30.0
- Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance
- Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.
Key exclusion criteria (23 listed)
- Diagnosis of diabetes
- Active pursuit of weight loss
- Poorly controlled hypertension or hypotension
- Untreated hypothyroidism or hyperthyroidism
- Anemia or abnormally functioning kidneys or liver
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 protein powder sachetmixed with 8 oz. water | Other | Experimental |
| Control protein powder sachetmixed with 8 oz. water | Other | Control |
Primary outcome
Protein Metabolism
Time frame: Change from - 1 to + 5 hours
Study Visit 1 and Study Visit 2
3 secondary outcomes
Macrovascular Blood Flow
Time frame: Change from -1 to +5 hours
Glycemic Markers
Time frame: Change from -1 to +5 hours
Microvascular Blood Flow
Time frame: Change from -1 to +5 hours
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 17 Jun 2016.
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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.
Min Tian, 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 study testing Experimental protein powder sachet in people with Malnutrition, run by Abbott Nutrition at 1 site in United Kingdom.
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 23 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 17 Jun 2016. 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 Kingdom. 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?
Protein Metabolism (time frame: Change from - 1 to + 5 hours). 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 17 Jun 2016.