Resonance Raman Spectroscopy for Dietary Carotenoid IntakeNCT01403844
Carotenoid Response to the Intake of Vegetables and Fruits
A study testing Carotenoid Depletion, Carotenoid Repletion and Natural Repletion in people with Resonance Raman Spectroscopy for Dietary Carotenoid Intake, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resonance Raman Spectroscopy for Dietary Carotenoid Intake
- What is being tested?
- Carotenoid Depletion, Carotenoid Repletion and Natural Repletion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 - 65 years
- Weight stable (±5 lbs) for at least 2 months prior to the start of the study
- Body mass index (BMI) between 19-30 kg/m2
- Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
- Willing to maintain baseline weight and physical activity levels
Who cannot join
- BMI greater than 30.
- Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
- Current smoker
- Allergies or intolerances to foods to be utilized in the study
- Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
- Pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines
The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.
Read the detailed description
This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.
- Being tested
- Carotenoid Depletion, Carotenoid Repletion, Natural Repletion
- Keywords
- resonance Raman spectroscopy, Dietary Guidelines, fruits, biomarkers, carotenoids, MyPlate, vegetables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid DepletionOther
Depletion of carotenoids using a restricted food list
Carotenoid RepletionOther
Carotenoid repletion with provided diet based on dietary guidelines.
Carotenoid DepletionOther
Carotenoid depletion using a restricted food list.
Natural RepletionOther
Resumption of usual personal diet regimen. No restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Skin Carotenoids | Other | Skin carotenoids will be measured under conditions of depletion or repletion Receives: Other: Carotenoid Depletion; Other: Carotenoid Repletion; Other: Natural Repletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and skin levels of carotenoids in adults fed a high carotenoid diet
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resonance Raman Spectroscopy for Dietary Carotenoid IntakeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403844
- Sponsor's protocol ID
- GFHNRC022
- Status last verified
- May 2020
- First submitted
- 21 Jul 2011
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.
PubMed 25008856
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines
- ClinicalTrials.gov ID
- NCT01403844
- Acronym / sponsor ID
- GFHNRC022
- Keywords
- resonance Raman spectroscopy, Dietary Guidelines, fruits, biomarkers, carotenoids, MyPlate, vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jun 2011 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Jul 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.
The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.
Detailed description
This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Carotenoids | Other | Other: Carotenoid Depletion, Other: Carotenoid Repletion, Other: Natural RepletionSkin carotenoids will be measured under conditions of depletion or repletion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 - 65 years
- Weight stable (±5 lbs) for at least 2 months prior to the start of the study
- Body mass index (BMI) between 19-30 kg/m2
- Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
- Willing to maintain baseline weight and physical activity levels
Key exclusion criteria (6 listed)
- BMI greater than 30.
- Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
- Current smoker
- Allergies or intolerances to foods to be utilized in the study
- Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
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 |
|---|---|---|
| Carotenoid DepletionDepletion of carotenoids using a restricted food list | Other | Skin Carotenoids |
| Carotenoid RepletionCarotenoid repletion with provided diet based on dietary guidelines. | Other | Skin Carotenoids |
| Carotenoid DepletionCarotenoid depletion using a restricted food list. | Other | Skin Carotenoids |
| Natural RepletionResumption of usual personal diet regimen. No restrictions. | Other | Skin Carotenoids |
Primary outcome
Serum and skin levels of carotenoids in adults fed a high carotenoid diet
Time frame: 28 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 20 May 2020.
- Derived from this study: PubMed 25008856Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.
- Grand Forks Human Nutrition Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotenoid Depletion, Carotenoid Repletion and Natural Repletion in people with Resonance Raman Spectroscopy for Dietary Carotenoid Intake, run by USDA Grand Forks Human Nutrition Research Center 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 5 inclusion and 6 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 20 May 2020. 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?
Serum and skin levels of carotenoids in adults fed a high carotenoid diet (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403844, which also lists 1 linked publication.
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 20 May 2020.