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Completed

NCT Number: NCT03202043

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose vegetable juice

Other

High dose (13 fl oz) vegetable juice

Medium dose vegetable juice

Other

Medium dose (10 fl oz) vegetable juice

Low dose vegetable juice

Other

Low dose (5.5 fl oz) vegetable juice

Control bottled water

Other

Control (12 fl oz) bottled water

Primary outcomes

  1. 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.

Secondary outcomes

  1. Usual intake of carotenoid-rich foods and beverages

    Time frame: 0,4,8 weeks

    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.

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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