Healthy SubjectsNCT02717234
Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
A study testing Oral Nutrition Supplement in people with Healthy Subjects, run by Société des Produits Nestlé (SPN).
Trial summary
To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Oral Nutrition Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
- Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
- Willing to provide signed informed consent
Who cannot join
- Smoker
- Patients with potential for non-compliance
- Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
- Subject who in the Investigator's assessment cannot be expected to comply with study protocol
- Currently participating in another conflicting clinical trial.
About this study
To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake
- Conditions
- Healthy Subjects
- Being tested
- Oral Nutrition Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutrition SupplementOther
Oral nutrition supplement intended for consumption at 3 servings per day
| Study group | Role | What they receive |
|---|---|---|
| Impact Advanced Recovery | Active comparator | Oral nutrition supplement intended for consumption at 3 servings per day Receives: Other: Oral Nutrition Supplement |
| Impact Advanced Recovery-R | Experimental | Oral nutrition supplement intended for consumption at 3 servings per day Receives: Other: Oral Nutrition Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma arginine levels in µmol/L
Measured: Pre-consumption, 30, 60, 120, 180, 240 minutes
Secondary outcomes (2)
Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml
Measured: Pre-consumption, 30, 60, 120, 180, 240 minutes
Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml
Measured: Pre-consumption, 30, 60, 120, 180, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherwyn Schwartz, MD, Principal investigator, Diabetes & Glandular Disease Clinic, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717234
- Sponsor's protocol ID
- 14.31.US.CLI
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2016
- Last updated
- 1 May 2023
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
- ClinicalTrials.gov ID
- NCT02717234
- Acronym / sponsor ID
- 14.31.US.CLI
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Mar 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.
To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact Advanced Recovery | Active comparator | Other: Oral Nutrition SupplementOral nutrition supplement intended for consumption at 3 servings per day |
| Impact Advanced Recovery-R | Experimental | Other: Oral Nutrition SupplementOral nutrition supplement intended for consumption at 3 servings per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
- Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
- Willing to provide signed informed consent
Key exclusion criteria (5 listed)
- Smoker
- Patients with potential for non-compliance
- Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
- Subject who in the Investigator's assessment cannot be expected to comply with study protocol
- Currently participating in another conflicting clinical trial.
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 |
|---|---|---|
| Oral Nutrition SupplementOral nutrition supplement intended for consumption at 3 servings per day | Other | Impact Advanced Recovery, Impact Advanced Recovery-R |
Primary outcome
Change in plasma arginine levels in µmol/L
Time frame: Pre-consumption, 30, 60, 120, 180, 240 minutes
2 secondary outcomes
Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml
Time frame: Pre-consumption, 30, 60, 120, 180, 240 minutes
Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml
Time frame: Pre-consumption, 30, 60, 120, 180, 240 minutes
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 2023.
- 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.
Sherwyn Schwartz, MD principal investigator
Diabetes & Glandular Disease Clinic, PA
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutrition Supplement in people with Healthy Subjects, run by Société des Produits Nestlé (SPN).
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 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in plasma arginine levels in µmol/L (time frame: Pre-consumption, 30, 60, 120, 180, 240 minutes). 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 2023.