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

May 15, 2013 updated by: Wayne Campbell, Purdue University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Investigators

  • Principal Investigator: Wayne Campbell, PhD, Purdue University
  • Principal Investigator: Mario Ferruzzi, PhD, Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 1102010527

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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