Cardiovascular Risk FactorNCT03175003
Assessment of a New Food Product in Metabolically at Risk Children
A study testing Food Product in people with Cardiovascular Risk Factor and Inflammation, run by University of California, Davis at 1 site in United States.
Trial summary
The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient… Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Inflammation, Micronutrient Deficiency
- What is being tested?
- Food Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 24 May 2018
- 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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or Female 9-13 years old
- Subject is willing and able to comply with the study protocols
- Subject is willing to consume the test products
- Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study
Who cannot join
- Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- Under current medical supervision
- Tanner Score = 4
- Non-English speaking
- Current participation in a daily exercise routine of moderate or high intensity
- Self-reported presence of disease, a history of serious illness, or who are currently under acute medical care.
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- Currently taking prescription drugs or supplements
- Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
- Self-reported malabsorption or gastrointestinal issues
- Current enrollee in a clinical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).
Read the detailed description
Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection.
- Being tested
- Food Product
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food ProductOther
Each food product will provide similar calories, but a different micro- and macro-nutrient composition
| Study group | Role | What they receive |
|---|---|---|
| Food Product 1 | Active comparator | Macronutrient similar to experimental, micronutrient lower than experimental Receives: Other: Food Product |
| Food Product 2 | Active comparator | Macronutrient lower than experimental, micronutrient similar to experimental Receives: Other: Food Product |
| Food Product 3 | Experimental | Experimental 1 Receives: Other: Food Product |
| Food Product 4 | Experimental | Experimental 2 Receives: Other: Food Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microvascular Function
Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
Measured: Compare change in baseline and 4 weeks
Secondary outcomes (3)
Change in Metabolome
Measured with Nuclear Magnetic Resonance (NMR)
Measured: Compare change in baseline and 4 weeks
Change in Lipidome
Measured by Ultra Performance Liquid Chromatography (UPLC) tandem mass-spectrometry
Measured: Compare change in baseline and 4 weeks
Change in Inflammatory Markers
Measured by immunoassay
Measured: Compare change in baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start15 Jun 2017
- Primary completion24 Mar 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, controlled, 4 parallel arm design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl L Keen, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175003
- Sponsor's protocol ID
- 1009239
- Status last verified
- May 2019
- First submitted
- 13 Feb 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Protein Intake and Micronutrient Fortification in Metabolically at Risk Children
- ClinicalTrials.gov ID
- NCT03175003
- Acronym / sponsor ID
- 1009239
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 24 Mar 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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 current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).
Detailed description
Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Double blind, controlled, 4 parallel arm design
| Arm | Type | Receives |
|---|---|---|
| Food Product 1 | Active comparator | Other: Food ProductMacronutrient similar to experimental, micronutrient lower than experimental |
| Food Product 2 | Active comparator | Other: Food ProductMacronutrient lower than experimental, micronutrient similar to experimental |
| Food Product 3 | Experimental | Other: Food ProductExperimental 1 |
| Food Product 4 | Experimental | Other: Food ProductExperimental 2 |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or Female 9-13 years old
- Subject is willing and able to comply with the study protocols
- Subject is willing to consume the test products
- Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study
Key exclusion criteria (10 listed)
- Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
- Under current medical supervision
- Tanner Score = 4
- Non-English speaking
- Current participation in a daily exercise routine of moderate or high intensity
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 |
|---|---|---|
| Food ProductEach food product will provide similar calories, but a different micro- and macro-nutrient composition | Other | Food Product 1, Food Product 2, Food Product 3, Food Product 4 |
Primary outcome
Change in Microvascular Function
Time frame: Compare change in baseline and 4 weeks
Measured by EndoPAT2000. A PAT (Peripheral Arterial Tone) ratio is created using the post and pre occlusion values
3 secondary outcomes
Change in Metabolome
Time frame: Compare change in baseline and 4 weeks
Change in Lipidome
Time frame: Compare change in baseline and 4 weeks
Change in Inflammatory Markers
Time frame: Compare change in baseline and 4 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 30 May 2019.
- 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.
Carl L Keen, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Product in people with Cardiovascular Risk Factor and Inflammation, run by University of California, Davis 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 4 inclusion and 10 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 30 May 2019. 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?
Change in Microvascular Function (time frame: Compare change in baseline and 4 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 30 May 2019.