Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2009
1 active site
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
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 30, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJanuary 17, 2013
January 1, 2013
11 months
October 30, 2009
January 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.
66 days
Study Arms (3)
A
EXPERIMENTALSubjects will be assigned to consume 3 grams soybean oil, 8 grams canola oil, and 20 grams butter that is added to a salad.
B
EXPERIMENTALSubjects will be assigned to consume 8 grams soybean oil, 20 grams canola oil, and 3 grams butter that is added to a salad.
C
EXPERIMENTALSubjects will be assigned to consume 20 grams soybean oil, 3 grams canola oil, and 8 grams butter that is added to a salad.
Interventions
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.
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.
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 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.
- 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.
You may not qualify if:
- Menopausal
- Diabetic
- Currently pregnant
- Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
- Use of lipid altering medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Purdue University
West Lafayette, Indiana, 47906, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Wayne Campbell, Ph.D.
Study Record Dates
First Submitted
October 30, 2009
First Posted
November 2, 2009
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
May 1, 2010
Last Updated
January 17, 2013
Record last verified: 2013-01