Effect of Meal Patterning on Carotenoid Absorption From Vegetables

Dietary Modification Clinical Trial

— S26  

Official title:

Effect of Meal Patterning on Carotenoid Absorption From Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856816
• Other study ID #: 1102010527
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: May 15, 2013
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• 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

• 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Bioavailability
• Carotenoid
• Dietary Modification

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma.		0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose	No