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Completed

NCT Number: NCT01403844

Carotenoid Response to the Intake of Vegetables and Fruits

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

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Key information

Conditions

Resonance Raman Spectroscopy for Dietary Carotenoid Intake

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotenoid Depletion

Other

Depletion of carotenoids using a restricted food list

Carotenoid Repletion

Other

Carotenoid repletion with provided diet based on dietary guidelines.

Natural Repletion

Other

Resumption of usual personal diet regimen. No restrictions.

Primary outcomes

  1. Serum and skin levels of carotenoids in adults fed a high carotenoid diet

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 27, 2011
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.