OverweightNCT03202043
The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
A study testing High dose vegetable juice, Medium dose vegetable juice and Low dose vegetable juice in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- High dose vegetable juice, Medium dose vegetable juice and Low dose vegetable juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2018to 21 May 2019
- 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
- BMI 18.5-29.9 kg/m2
Who cannot join
- weigh less than 110 lbs
- currently dieting to lose weight
- allergic to tomatoes or vegetables
- pregnant, lactating, or planning to become pregnant
- currently use tobacco products or vape
- eat more that 2 cups of vegetables per day
Show all 10Show fewer
- have high blood sugar (≥200 mg/dL)
- have high blood pressure (≥140/90 mm Hg)
- have a medical condition such as diabetes or high blood pressure
- taking medication that lowers cholesterol or triglycerides
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables
This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.
Read the detailed description
The US Dietary Guidelines for Americans recommends that individuals consume approximately 2-4 c of vegetables each day to reduce risk of chronic disease, but current methods for assessing intake are either inaccurate (self-report) or invasive (blood carotenoid levels). Recent research indicates that skin carotenoid status may be a useful biomarker of vegetable intake, but the sensitivity to dose in unknown. In this study, we propose to test the dose-response of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control group receiving water). We will test skin carotenoids in two ways: using resonance Raman spectroscopy (RRS), which we have previously validated, and with a new technique, pressure mediated reflection spectroscopy (RS; the "Veggie Meter"). We will compare the two techniques during an 8-week provided tomato-based juice intervention. Skin carotenoid readings will be compared to blood carotenoid concentrations and single nucleotide polymorphisms (SNPs) of genes related to the uptake, transport, and metabolism of carotenoids will be examined in blood and saliva.
- Conditions
- Overweight
- Being tested
- High dose vegetable juice, Medium dose vegetable juice, Low dose vegetable juice, Control bottled water
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose vegetable juiceOther
High dose (13 fl oz) vegetable juice
Medium dose vegetable juiceOther
Medium dose (10 fl oz) vegetable juice
Low dose vegetable juiceOther
Low dose (5.5 fl oz) vegetable juice
Control bottled waterOther
Control (12 fl oz) bottled water
| Study group | Role | What they receive |
|---|---|---|
| High dose vegetable juice | Experimental | Subject will consume high dose vegetable juice daily for 8 weeks. Receives: Other: High dose vegetable juice |
| Medium dose vegetable juice | Experimental | Subject will consume medium dose vegetable juice daily for 8 weeks. Receives: Other: Medium dose vegetable juice |
| Low dose vegetable juice | Experimental | Subject will consume low dose vegetable juice daily for 8 weeks. Receives: Other: Low dose vegetable juice |
| Control bottled water | Other | Subject will consume control bottled water daily for 8 weeks. Receives: Other: Control bottled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin carotenoid concentration as measured by pressure-mediated reflection spectroscopy (RS)
Pressure-mediated reflection spectroscopy (RS) is used to measure tissue carotenoids. RS intensity can be used as a measure for total carotenoid content in the measured tissue volume.
Measured: 0, 4, 8 weeks
Secondary outcomes (1)
Usual intake of carotenoid-rich foods and beverages
A 44-item food frequency questionnaire of the top carotenoid-rich foods and beverages will be developed to measure carotenoid intake from a person's usual diet.
Measured: 0,4,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start6 Apr 2018
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- None (open label)
- Enrolment
- 80 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
- NCT03202043
- Sponsor's protocol ID
- GFHNRC150
- Status last verified
- May 2022
- First submitted
- 26 Jun 2017
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norman AC, Palmer DG, Moran NE, Roemmich JN, Casperson SL. Association of Candidate Single-Nucleotide Polymorphism Genotypes With Plasma and Skin Carotenoid Concentrations in Adults Provided a Lycopene-Rich Juice. J Nutr. 2024 Jul;154(7):1985-1993. doi: 10.1016/j.tjnut.2024.05.022. Epub 2024 May 24.
PubMed 38797482Casperson SL, Roemmich JN, Larson KJ, Hess JM, Palmer DG, Jahns L. Sensitivity of Pressure-Mediated Reflection Spectroscopy to Detect Changes in Skin Carotenoids in Adults Without Obesity in Response to Increased Carotenoid Intake: A Randomized Controlled Trial. J Nutr. 2023 Feb;153(2):588-597. doi: 10.1016/j.tjnut.2023.01.002. Epub 2023 Jan 6.
PubMed 36894250
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables
- ClinicalTrials.gov ID
- NCT03202043
- Acronym / sponsor ID
- GFHNRC150
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 28 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.
This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.
Detailed description
The US Dietary Guidelines for Americans recommends that individuals consume approximately 2-4 c of vegetables each day to reduce risk of chronic disease, but current methods for assessing intake are either inaccurate (self-report) or invasive (blood carotenoid levels). Recent research indicates that skin carotenoid status may be a useful biomarker of vegetable intake, but the sensitivity to dose in unknown. In this study, we propose to test the dose-response of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control group receiving water). We will test skin carotenoids in two ways: using resonance Raman spectroscopy (RRS), which we have previously validated, and with a new technique, pressure mediated reflection spectroscopy (RS; the "Veggie Meter"). We will compare the two techniques during an 8-week provided tomato-based juice intervention. Skin carotenoid readings will be compared to blood carotenoid concentrations and single nucleotide polymorphisms (SNPs) of genes related to the uptake, transport, and metabolism of carotenoids will be examined in blood and saliva.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose vegetable juice | Experimental | Other: High dose vegetable juiceSubject will consume high dose vegetable juice daily for 8 weeks. |
| Medium dose vegetable juice | Experimental | Other: Medium dose vegetable juiceSubject will consume medium dose vegetable juice daily for 8 weeks. |
| Low dose vegetable juice | Experimental | Other: Low dose vegetable juiceSubject will consume low dose vegetable juice daily for 8 weeks. |
| Control bottled water | Other | Other: Control bottled waterSubject will consume control bottled water daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 18.5-29.9 kg/m2
Key exclusion criteria (10 listed)
- weigh less than 110 lbs
- currently dieting to lose weight
- allergic to tomatoes or vegetables
- pregnant, lactating, or planning to become pregnant
- currently use tobacco products or vape
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 |
|---|---|---|
| High dose vegetable juiceHigh dose (13 fl oz) vegetable juice | Other | High dose vegetable juice |
| Medium dose vegetable juiceMedium dose (10 fl oz) vegetable juice | Other | Medium dose vegetable juice |
| Low dose vegetable juiceLow dose (5.5 fl oz) vegetable juice | Other | Low dose vegetable juice |
| Control bottled waterControl (12 fl oz) bottled water | Other | Control bottled water |
Primary outcome
Change in skin carotenoid concentration as measured by pressure-mediated reflection spectroscopy (RS)
Time frame: 0, 4, 8 weeks
Pressure-mediated reflection spectroscopy (RS) is used to measure tissue carotenoids. RS intensity can be used as a measure for total carotenoid content in the measured tissue volume.
1 secondary outcome
Usual intake of carotenoid-rich foods and beverages
Time frame: 0,4,8 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 16 May 2022.
- Derived from this study: PubMed 38797482Norman AC, Palmer DG, Moran NE, Roemmich JN, Casperson SL. Association of Candidate Single-Nucleotide Polymorphism Genotypes With Plasma and Skin Carotenoid Concentrations in Adults Provided a Lycopene-Rich Juice. J Nutr. 2024 Jul;154(7):1985-1993. doi: 10.1016/j.tjnut.2024.05.022. Epub 2024 May 24.
- Derived from this study: PubMed 36894250Casperson SL, Roemmich JN, Larson KJ, Hess JM, Palmer DG, Jahns L. Sensitivity of Pressure-Mediated Reflection Spectroscopy to Detect Changes in Skin Carotenoids in Adults Without Obesity in Response to Increased Carotenoid Intake: A Randomized Controlled Trial. J Nutr. 2023 Feb;153(2):588-597. doi: 10.1016/j.tjnut.2023.01.002. Epub 2023 Jan 6.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 High dose vegetable juice, Medium dose vegetable juice and Low dose vegetable juice in people with Overweight, 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 1 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 16 May 2022. 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 skin carotenoid concentration as measured by pressure-mediated reflection spectroscopy (RS) (time frame: 0, 4, 8 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 NCT03202043, which also lists 2 linked publications.
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 16 May 2022.