Human VolunteersPhase 2NCT01464385
Nutrition Beverage Tolerance Study
A Phase 2 study testing Nutritional Beverage in people with Human Volunteers, run by Abbott Nutrition at 1 site in United States.
Trial summary
To evaluate the sensations experienced by subjects consuming a nutritional beverage. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- Nutritional Beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2011
- Phase
- Phase 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject ≥ 45 years of age.
- If female, subject is either postmenopausal for at least 1 year or surgically sterile
- Subject reports that he/she has not participated in a research study in the last three months.
Who cannot join
- Subject has active metabolic or endocrine disease
- Subject has an autoimmune disorder
- Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.
- Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products
- Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the sensations experienced by subjects consuming a nutritional beverage.
- Conditions
- Human Volunteers
- Being tested
- Nutritional Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional BeverageOther
Nutritional Beverage Oral 237mL
Nutritional BeverageOther
Nutritional Beverage Oral 237 mL
Nutritional BeverageOther
Nutritional Beverage Oral 237mL
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Beverage #2 | Experimental | Nutritional Beverage with an amino acid Oral 237 ml Receives: Other: Nutritional Beverage |
| Nutritional Beverage #3 | Experimental | Nutritional Beverage with an amino acid Oral 237 ml Receives: Other: Nutritional Beverage |
| Nutritional Beverage #1 | Placebo comparator | Nutritional Beverage Oral 237 ml Receives: Other: Nutritional Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects experiencing neurologic adverse event(s)
Measured: 2-3 weeks
Secondary outcomes (1)
Proportion of subjects experiencing any adverse event(s).
Measured: 2-3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human VolunteersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 121 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464385
- Sponsor's protocol ID
- BK98
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 2011
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Beverage Tolerance Study
- ClinicalTrials.gov ID
- NCT01464385
- Acronym / sponsor ID
- BK98
- Conditions
- Human Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Nov 2011 (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 sensations experienced by subjects consuming a nutritional beverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutritional Beverage #2 | Experimental | Other: Nutritional BeverageNutritional Beverage with an amino acid Oral 237 ml |
| Nutritional Beverage #3 | Experimental | Other: Nutritional BeverageNutritional Beverage with an amino acid Oral 237 ml |
| Nutritional Beverage #1 | Placebo comparator | Other: Nutritional BeverageNutritional Beverage Oral 237 ml |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject ≥ 45 years of age.
- If female, subject is either postmenopausal for at least 1 year or surgically sterile
- Subject reports that he/she has not participated in a research study in the last three months.
Key exclusion criteria (5 listed)
- Subject has active metabolic or endocrine disease
- Subject has an autoimmune disorder
- Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.
- Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products
- Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening
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 |
|---|---|---|
| Nutritional BeverageNutritional Beverage Oral 237mL | Other | Nutritional Beverage #1 |
| Nutritional BeverageNutritional Beverage Oral 237 mL | Other | Nutritional Beverage #2 |
| Nutritional BeverageNutritional Beverage Oral 237mL | Other | Nutritional Beverage #3 |
Primary outcome
Proportion of subjects experiencing neurologic adverse event(s)
Time frame: 2-3 weeks
1 secondary outcome
Proportion of subjects experiencing any adverse event(s).
Time frame: 2-3 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 1 May 2012.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutritional Beverage in people with Human Volunteers, 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 3 inclusion and 5 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 1 May 2012. 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 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.
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?
Proportion of subjects experiencing neurologic adverse event(s) (time frame: 2-3 weeks). 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 1 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.