- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432210
Provitamin A Absorption and Conversion With Avocados
Enhancing Human Intestinal Absorption of Carotenoids and Bioconversion of Carotene to Vitamin A in the Presence of Hass Avocados
Study Overview
Detailed Description
The primary objective of this study will be to demonstrate that adding avocados to a carotene rich meal will promote the absorption of provitamin A carotenoids and enhance the delivery of greater quantities of vitamin A. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites after subjects consume a meal with or without avocado in combination with a serving of tomato sauce (containing nutritionally relevant amounts of beta-carotene) or carrots.
The secondary objective of this study will be to determine if higher levels of carotenoids and other antioxidants transported in the bloodstream will have a protective role in promoting cardiovascular health. This objective will be accomplished by testing the oxidation capacity of lipoprotein fractions before and after meal supplementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Clinical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Total cholesterol (140 to 200 mg/dL)
- BMI 17 to 30
- Age 18-70 years
Exclusion Criteria:
- Lactating, pregnant, or plan to be pregnant during study
- Tobacco use (cigarettes or chewing tobacco)
- Metabolic disease
- Malabsorption disorders
- History of cancer, esophageal, gastric, or intestinal ulcers
- History of liver or kidney insufficiency or failure
- Allergies to tomatoes or tomato products
- Allergies to carrots
- Allergies to avocados
- Obesity (BMI>30)
- Hypercholesterolemia (total cholesterol> 200mg/dL)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Tomato Meal
A tomato meal will be fed with and without avocado.
|
|
Other: Carrot Meal
A carrot meal will be fed with and without avocado.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-prandial levels of provitamin A and vitamin A
Time Frame: Nine post-prandial blood samples will be taken over twelve hours
|
The absorption of and conversion of provitamin A carotenoids into vitamin A will be measured after the consumption of a carotenoid-rich meal.
The meal will be served both with and without avocado as a source of lipid.
|
Nine post-prandial blood samples will be taken over twelve hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-prandial antioxidant status of blood
Time Frame: comparing baseline vs. 5 hour status
|
The ability of a carotenoid-rich meal to reduce the susceptibility of blood lipoproteins to oxidative stress will be tested.
A modified trolox equivalent antioxidant capacity (TEAC) assay will be used.
|
comparing baseline vs. 5 hour status
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven J Schwartz, Ph.D., Ohio State University
Publications and helpful links
General Publications
- Cooperstone JL, Goetz HJ, Riedl KM, Harrison EH, Schwartz SJ, Kopec RE. Relative contribution of alpha-carotene to postprandial vitamin A concentrations in healthy humans after carrot consumption. Am J Clin Nutr. 2017 Jul;106(1):59-66. doi: 10.3945/ajcn.116.150821. Epub 2017 May 17.
- Kopec RE, Cooperstone JL, Schweiggert RM, Young GS, Harrison EH, Francis DM, Clinton SK, Schwartz SJ. Avocado consumption enhances human postprandial provitamin A absorption and conversion from a novel high-beta-carotene tomato sauce and from carrots. J Nutr. 2014 Aug;144(8):1158-66. doi: 10.3945/jn.113.187674. Epub 2014 Jun 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2011H0159
- 60030575 (Other Identifier: OSURF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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