The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables
1 other identifier
interventional
80
1 country
1
Brief Summary
This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedStudy Start
First participant enrolled
April 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2019
CompletedMay 16, 2022
May 1, 2022
1.1 years
June 26, 2017
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0, 4, 8 weeks
Secondary Outcomes (1)
Usual intake of carotenoid-rich foods and beverages
0,4,8 weeks
Study Arms (4)
High dose vegetable juice
EXPERIMENTALSubject will consume high dose vegetable juice daily for 8 weeks.
Medium dose vegetable juice
EXPERIMENTALSubject will consume medium dose vegetable juice daily for 8 weeks.
Low dose vegetable juice
EXPERIMENTALSubject will consume low dose vegetable juice daily for 8 weeks.
Control bottled water
OTHERSubject will consume control bottled water daily for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- BMI 18.5-29.9 kg/m2
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203, United States
Related Publications (2)
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.
PMID: 38797482DERIVEDCasperson 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.
PMID: 36894250DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Roemmich, PhD
USDA Grand Forks Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2017
First Posted
June 28, 2017
Study Start
April 6, 2018
Primary Completion
May 21, 2019
Study Completion
May 21, 2019
Last Updated
May 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share