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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High dose vegetable juice
Medium dose vegetable juice
Low dose vegetable juice
Control bottled water
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

High dose vegetable juice

Medium dose vegetable juice

Low dose vegetable juice

Control bottled water

Arm Description

Subject will consume high dose vegetable juice daily for 8 weeks.

Subject will consume medium dose vegetable juice daily for 8 weeks.

Subject will consume low dose vegetable juice daily for 8 weeks.

Subject will consume control bottled water daily for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2017
Last Updated
May 9, 2022
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03202043
Brief Title
The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
Official Title
Sensitivity of Skin Carotenoid Status to Detect Changes in Intake of Varying Levels of Vegetables
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
May 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose vegetable juice
Arm Type
Experimental
Arm Description
Subject will consume high dose vegetable juice daily for 8 weeks.
Arm Title
Medium dose vegetable juice
Arm Type
Experimental
Arm Description
Subject will consume medium dose vegetable juice daily for 8 weeks.
Arm Title
Low dose vegetable juice
Arm Type
Experimental
Arm Description
Subject will consume low dose vegetable juice daily for 8 weeks.
Arm Title
Control bottled water
Arm Type
Other
Arm Description
Subject will consume control bottled water daily for 8 weeks.
Intervention Type
Other
Intervention Name(s)
High dose vegetable juice
Intervention Description
High dose (13 fl oz) vegetable juice
Intervention Type
Other
Intervention Name(s)
Medium dose vegetable juice
Intervention Description
Medium dose (10 fl oz) vegetable juice
Intervention Type
Other
Intervention Name(s)
Low dose vegetable juice
Intervention Description
Low dose (5.5 fl oz) vegetable juice
Intervention Type
Other
Intervention Name(s)
Control bottled water
Intervention Description
Control (12 fl oz) bottled water
Primary Outcome Measure Information:
Title
Change in skin carotenoid concentration as measured by pressure-mediated reflection spectroscopy (RS)
Description
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.
Time Frame
0, 4, 8 weeks
Secondary Outcome Measure Information:
Title
Usual intake of carotenoid-rich foods and beverages
Description
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.
Time Frame
0,4,8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies

Learn more about this trial

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

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