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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01403844 |
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Date of registration:
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21/07/2011 |
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Primary sponsor: |
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Public title:
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Carotenoid Response to the Intake of Vegetables and Fruits
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Scientific title:
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Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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31 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01403844 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Leah Whigham, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Agricultural Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center |
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Name:
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Lisa Jahns, PhD, RD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Agricultural Research Service, United States Department of Agriculture, Grand Forks Human Nutrition Research Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Resonance Raman Spectroscopy for Dietary Carotenoid Intake
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Intervention(s)
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Other: Carotenoid Depletion
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Other: Carotenoid Repletion
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Other: Natural Repletion
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Primary Outcome(s)
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Serum and skin levels of carotenoids in adults fed a high carotenoid diet
[Time Frame: 28 weeks]
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Secondary ID(s)
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GFHNRC022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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