Carotenoid Response to the Intake of Vegetables and Fruits

May 18, 2020 updated by: USDA Grand Forks Human Nutrition Research Center

Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines

The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58203
        • Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged 18 - 65 years
  • Weight stable (±5 lbs) for at least 2 months prior to the start of the study
  • Body mass index (BMI) between 19-30 kg/m2
  • Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
  • Willing to maintain baseline weight and physical activity levels

Exclusion Criteria:

  1. BMI greater than 30.
  2. Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
  3. Current smoker
  4. Allergies or intolerances to foods to be utilized in the study
  5. Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
  6. Pregnancy or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Skin Carotenoids
Skin carotenoids will be measured under conditions of depletion or repletion
Other: Carotenoid Depletion
Depletion of carotenoids using a restricted food list
Other: Carotenoid Repletion
Carotenoid repletion with provided diet based on dietary guidelines.
Other: Carotenoid Depletion
Carotenoid depletion using a restricted food list.
Other: Natural Repletion
Resumption of usual personal diet regimen. No restrictions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum and skin levels of carotenoids in adults fed a high carotenoid diet
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFHNRC022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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