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: July 7, 2014
Last verified: July 2014
  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 2015
Estimated Primary Completion Date: December 2015 (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
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:

  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
  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
Principal Investigator: Leah Whigham, PhD Agricultural Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center
  More Information

Additional Information:
No publications provided

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: July 7, 2014
Health Authority: United States: Federal Government

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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014