Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Carotenoid Response to the Intake of Vegetables and Fruits

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403844
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
USDA Grand Forks Human Nutrition Research Center

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

Condition or disease Intervention/treatment Phase
Resonance Raman Spectroscopy for Dietary Carotenoid Intake Other: Carotenoid Depletion Other: Carotenoid Repletion Other: Natural Repletion Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines
Actual Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Serum and skin levels of carotenoids in adults fed a high carotenoid diet [ Time Frame: 28 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403844


Locations
Layout table for location information
United States, North Dakota
Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58203
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Layout table for investigator information
Principal Investigator: James Roemmich, PhD USDA Grand Forks Human Nutrition Research Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01403844    
Other Study ID Numbers: GFHNRC022
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by USDA Grand Forks Human Nutrition Research Center:
resonance Raman spectroscopy
Dietary Guidelines
fruits
biomarkers
carotenoids
MyPlate
vegetables
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs