Carotenoid Response to the Intake of Vegetables and Fruits

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ClinicalTrials.gov Identifier: NCT01403844

Recruitment Status : Completed

First Posted : July 27, 2011

Last Update Posted : September 26, 2017

Sponsor:

Information provided by (Responsible Party):

Lisa Jahns, USDA Grand Forks Human Nutrition Research Center

Study Description

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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:

BMI greater than 30.
Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
Current smoker
Allergies or intolerances to foods to be utilized in the study
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)
Pregnancy or lactating

Contacts and Locations

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


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


Principal Investigator:	Lisa Jahns, PhD, RD	Agricultural Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center

More Information

Additional Information:

Grand Forks Human Nutrition Research Center This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.


Responsible Party:	Lisa Jahns, PhD, RD, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:	NCT01403844 History of Changes
Other Study ID Numbers:	GFHNRC022
First Posted:	July 27, 2011 Key Record Dates
Last Update Posted:	September 26, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Lisa Jahns, USDA Grand Forks Human Nutrition Research Center:


resonance Raman spectroscopy Dietary Guidelines fruits biomarkers	carotenoids MyPlate vegetables

Additional relevant MeSH terms:


Carotenoids Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

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