Effect of Meal Patterning on Carotenoid Absorption From Vegetables
S26
1 other identifier
interventional
6
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedMay 17, 2013
May 1, 2013
2 months
May 15, 2013
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
EXPERIMENTALA 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.
Meal Pattern Treatment B
EXPERIMENTALA 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.
Treatment Group C
OTHERA 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.
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.
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.
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.
Eligibility Criteria
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
- PRINCIPAL INVESTIGATOR
Mario Ferruzzi, PhD
Purdue University
- PRINCIPAL INVESTIGATOR
Wayne Campbell, PhD
Purdue University
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