NCT01856816

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

2 months

First QC Date

May 15, 2013

Last Update Submit

May 15, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Meal Pattern Treatment A

EXPERIMENTAL

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

Meal Pattern Treatment B

EXPERIMENTAL

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

Treatment Group C

OTHER

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

Interventions

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 A

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 B

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.

Treatment Group C

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetic
  • Use of lipid altering medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mario Ferruzzi, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR
  • Wayne Campbell, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Foods and Nutrition

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 17, 2013

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

May 17, 2013

Record last verified: 2013-05