Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT01006174
First received: October 30, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Absorption of Carotenoids From Vegetables
Other: Soybean Oil
Other: Canola Oil
Other: Butter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables. [ Time Frame: 66 days ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006174

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47906
Sponsors and Collaborators
Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT01006174     History of Changes
Other Study ID Numbers: 0707005641
Study First Received: October 30, 2009
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014