Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

January 16, 2013 updated by: Wayne Campbell, Purdue University
The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Purdue University

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

All

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.
  • Must be pre-menopausal
  • 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 or planned pregnancy
  • Not using any hormone-based contraceptive, e.g., pill, patch, injection, implants, etc.
  • 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:

  • Menopausal
  • Diabetic
  • Currently pregnant
  • Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
  • 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Subjects will be assigned to consume 3 grams soybean oil, 8 grams canola oil, and 20 grams butter that is added to a salad.
Other: Soybean Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad.
Other: Canola Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad.
Other: Butter
Depending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad.
Experimental: B
Subjects will be assigned to consume 8 grams soybean oil, 20 grams canola oil, and 3 grams butter that is added to a salad.
Other: Soybean Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad.
Other: Canola Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad.
Other: Butter
Depending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad.
Experimental: C
Subjects will be assigned to consume 20 grams soybean oil, 3 grams canola oil, and 8 grams butter that is added to a salad.
Other: Soybean Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad.
Other: Canola Oil
Depending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad.
Other: Butter
Depending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.
Time Frame: 66 days
66 days

Collaborators and Investigators

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

Sponsor

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

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 0707005641

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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