HealthyNCT02732158
Novel Laboratory Methods in Nutrition Studies
A study testing Nutrition Products in people with Healthy, run by Abbott Nutrition at 1 site in United States.
Trial summary
This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nutrition Products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must agree to refrain from taking supplements other than study product.
- Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.
Who cannot join
- Body Mass Index (BMI) > or equal to 35 kg/m2
- Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
- Has stated active malignant disease
- Has a known history of chronic renal parenchymal disease
- Has a known history of severe liver disease/liver failure
- Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures
- Known allergy or intolerance to any study product ingredient
- Participation in another study that has not been approved as a concomitant study
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University, Center for Translation Research in Aging and Longevity
College Station, Texas, 77843-4253
About this study
Official title: Feasibility of Novel Laboratory Methods for Use in Nutrition Studies
This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.
- Conditions
- Healthy
- Being tested
- Nutrition Products
- Keywords
- Novel laboratory methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition ProductsOther
a sachet containing AN777and amino acids; a carotenoid capsule
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Products | Experimental | Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day Receives: Other: Nutrition Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of lab values from venipuncture and DBS methods
Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.
Measured: Baseline
Secondary outcomes (3)
Change in AN777
Measured: Baseline to Day 60
Change in carotenoids
Measured: Baseline to Day 60
Compliance of study product consumption
Subject Questionnaire
Measured: Baseline to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolyn Alish, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732158
- Sponsor's protocol ID
- BL27
- Status last verified
- Mar 2017
- First submitted
- 4 Apr 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Novel Laboratory Methods for Use in Nutrition Studies
- ClinicalTrials.gov ID
- NCT02732158
- Acronym / sponsor ID
- BL27
- Conditions
- Healthy
- Keywords
- Novel laboratory methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Apr 2016 (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 prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Products | Experimental | Other: Nutrition ProductsTwo servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant must agree to refrain from taking supplements other than study product.
- Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.
Key exclusion criteria (8 listed)
- Body Mass Index (BMI) > or equal to 35 kg/m2
- Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
- Has stated active malignant disease
- Has a known history of chronic renal parenchymal disease
- Has a known history of severe liver disease/liver failure
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 |
|---|---|---|
| Nutrition Productsa sachet containing AN777and amino acids; a carotenoid capsule | Other | Nutrition Products |
Primary outcome
Comparison of lab values from venipuncture and DBS methods
Time frame: Baseline
Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.
3 secondary outcomes
Change in AN777
Time frame: Baseline to Day 60
Change in carotenoids
Time frame: Baseline to Day 60
Compliance of study product consumption
Time frame: Baseline to Day 60
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 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Carolyn Alish, PhD, RD 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 Nutrition Products in people with Healthy, 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 2 inclusion and 8 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 27 Mar 2017. 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. 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?
Comparison of lab values from venipuncture and DBS methods (time frame: Baseline). 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 27 Mar 2017.