The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake

Overweight Clinical Trial

Official title:

Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202043
• Other study ID #: GFHNRC150
• Status: Completed
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: May 21, 2019

Study information

• Verified date: May 2022
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-29.9 kg/m2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• High dose vegetable juice
High dose (13 fl oz) vegetable juice
• Medium dose vegetable juice
Medium dose (10 fl oz) vegetable juice
• Low dose vegetable juice
Low dose (5.5 fl oz) vegetable juice
• Control bottled water
Control (12 fl oz) bottled water

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0,4,8 weeks

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies