Raman SpectroscopyNCT03146715
The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children
A study testing Feeding trial in people with Raman Spectroscopy and Children, Only, run by Utah State University at 1 site in United States.
Trial summary
Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Raman Spectroscopy, Children, Only
- What is being tested?
- Feeding trial
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 30 Jun 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Skin carotenoid levels 11,000-33,000 Raman intensity counts
- Age 5-18 years
- Willing to attend 7 clinic visits
- Willing to eat designated food each day for 6 weeks
Who cannot join
- Illness in two weeks before study began
- Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes
- Skin carotenoid levels <11,000 and >33,000 Raman intensity counts
- Consumption of high carotenoid supplements
- Use of topical self-tanning lotion
Trial locations and contacts
1 site in 1 country.
United States1 site
Utah State University, Center for Human Nutrition Studies
Logan, Utah, 84322-9815
About this study
Official title: The Effect of a Nutrient Dense Food on the Skin Carotenoid Levels of School Age Children
Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers.
Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children.
Read more
Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded.
Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks.
Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.
- Conditions
- Raman Spectroscopy, Children, Only
- Being tested
- Feeding trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding trialOther
Children were asked to eat the designated portion of the assigned food once a day for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-carotenoid food feeding trial | Active comparator | Twenty-three children were randomly assigned to a treatment with a high carotenoid baked food (4.3mg carotenoids/120g, 360 kcal) Receives: Other: Feeding trial |
| No-carotenoid food feeding trial | Placebo comparator | Twenty-five children were randomly assigned to consume a baked food with no carotenoids (300 kcals/73g) Receives: Other: Feeding trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raman resonance spectroscopy
The skin carotenoid levels were determined by calculating the average height of the peak Raman absorbance signal obtained and quantified from excitation of skin carotenoids using a low-intensity blue light-emitting diodes light (λ=473 nm) with green light (510 nm) detection.24 The BioPhotonic Scanner Everest 2TM skin carotenoids were reported as Raman intensity counts. The higher the count, the higher the concentration of carotenoid molecules detected at the site of measurement. The scanner reports total carotenoid count, rather than individual carotenoid counts, as there is overlap in the absorption spectra of each carotenoid. During the warm-up process, the black calibration cap, which covers the scanner's light-emitting diodes light, allows the scanner to self-calibrate using a patented process.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Apr 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raman SpectroscopyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Collaborators
- Utah Agriculture Experiment Station
- Responsible party
- Sponsor
- Investigators
- Karin Allen, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146715
- Sponsor's protocol ID
- USU #6351
- Status last verified
- May 2017
- First submitted
- 20 Apr 2017
- Last updated
- 10 May 2017
- 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 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutrient Dense Food on the Skin Carotenoid Levels of School Age Children
- ClinicalTrials.gov ID
- NCT03146715
- Acronym / sponsor ID
- USU #6351
- Conditions
- Raman Spectroscopy, Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Collaborators
- Utah Agriculture Experiment Station
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 10 May 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.
Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers.
Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children.
Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded.
Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks.
Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-carotenoid food feeding trial | Active comparator | Other: Feeding trialTwenty-three children were randomly assigned to a treatment with a high carotenoid baked food (4.3mg carotenoids/120g, 360 kcal) |
| No-carotenoid food feeding trial | Placebo comparator | Other: Feeding trialTwenty-five children were randomly assigned to consume a baked food with no carotenoids (300 kcals/73g) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Skin carotenoid levels 11,000-33,000 Raman intensity counts
- Age 5-18 years
- Willing to attend 7 clinic visits
- Willing to eat designated food each day for 6 weeks
Key exclusion criteria (5 listed)
- Illness in two weeks before study began
- Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes
- Skin carotenoid levels <11,000 and >33,000 Raman intensity counts
- Consumption of high carotenoid supplements
- Use of topical self-tanning lotion
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 |
|---|---|---|
| Feeding trialChildren were asked to eat the designated portion of the assigned food once a day for six weeks. | Other | High-carotenoid food feeding trial, No-carotenoid food feeding trial |
Primary outcome
Raman resonance spectroscopy
Time frame: 6 weeks
The skin carotenoid levels were determined by calculating the average height of the peak Raman absorbance signal obtained and quantified from excitation of skin carotenoids using a low-intensity blue light-emitting diodes light (λ=473 nm) with green light (510 nm) detection.24 The BioPhotonic Scanner Everest 2TM skin carotenoids were reported as Raman intensity counts. The higher the count, the higher the concentration of carotenoid molecules detected at the site of measurement. The scanner reports total carotenoid count, rather than individual carotenoid counts, as there is overlap in the absorption spectra of each carotenoid. During the warm-up process, the black calibration cap, which covers the scanner's light-emitting diodes light, allows the scanner to self-calibrate using a patented process.
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 10 May 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.
Karin Allen, PhD principal investigator
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding trial in people with Raman Spectroscopy and Children, Only, run by Utah State University 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 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 10 May 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. 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.
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?
Raman resonance spectroscopy (time frame: 6 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 10 May 2017.