Carotenoid Response to the Intake of Vegetables and Fruits

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Lisa Jahns, USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT01403844

First received: July 21, 2011

Last updated: September 12, 2016

Last verified: September 2016

History of Changes

Purpose

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

Condition	Intervention
Resonance Raman Spectroscopy for Dietary Carotenoid Intake	Other: Carotenoid Depletion Other: Carotenoid Repletion Other: Natural Repletion


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:

Serum and skin levels of carotenoids in adults fed a high carotenoid diet [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	31
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2017
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received:	July 21, 2011
Last Updated:	September 12, 2016
Health Authority:	United States: Federal Government
Individual Participant Data
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:


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

ClinicalTrials.gov processed this record on September 27, 2016

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