Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

Absorption of Carotenoids From Vegetables Clinical Trial

Official title:

Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006174
• Other study ID #: 0707005641
• Status: Completed
• Phase: N/A
• First received: October 30, 2009
• Last updated: January 16, 2013
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2013
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Absorption of Carotenoids From Vegetables

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.		66 days	Yes