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Effect of Meal Patterning on Carotenoid Absorption From Vegetables (S26)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856816
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carotenoid Bioavailability Dietary Modification Other: Meal Pattern Treatment A Other: Meal Pattern Treatment B Other: Meal Pattern Treatment C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Official Title: Effect of Meal Patterning on Carotenoid Absorption From Vegetables
Study Start Date : May 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: Meal Pattern Treatment A
A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group A.
Other: Meal Pattern Treatment A
In treatment A, subjects consumed 100% of salad vegetables and canola oil in the first meal and 0% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.

Experimental: Meal Pattern Treatment B
A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group B.
Other: Meal Pattern Treatment B
In treatment B, subjects consumed 50% of salad vegetables and canola oil in the first meal and 50% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.

Treatment Group C
A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group C.
Other: Meal Pattern Treatment C
In treatment C, subjects consumed 75% of vegetables and oil in the first meal and 25% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.




Primary Outcome Measures :
  1. Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma. [ Time Frame: 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856816


Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Mario Ferruzzi, PhD Purdue University
Principal Investigator: Wayne Campbell, PhD Purdue University
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Responsible Party: Wayne Campbell, Prof. Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT01856816    
Other Study ID Numbers: 1102010527
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013