Dietary Modification Clinical Trial
— S26Official title:
Effect of Meal Patterning on Carotenoid Absorption From Vegetables
Verified date | May 2013 |
Source | Purdue University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this research study is to determine how different meal patterns influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that carotenoid absorption will be lower when daily vegetables are consumed in one meal compared two smaller meals throughout the day.
Status | Completed |
Enrollment | 6 |
Est. completion date | August 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion criteria: - Age range: 18-50 years - Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m² - Weight stable (<4.5 kg change within the last 3 months) - Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months - Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of =110 mg/dl) - Non-smoking - Non-diabetic - No current use of medication affecting lipid profile - No intestinal disorders including lipid malabsorption, lactose intolerance - No heavy consumption of alcohol (>2 drinks per day) - No current use of dietary supplements that affect cholesterol, (e.g. Benocol or fiber supplements) or a willingness to discontinue their use during the study Exclusion criteria: - Diabetic - Use of lipid altering medications |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Purdue University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma. | 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose | No |
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