NCT02867488

Brief Summary

The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

August 11, 2016

Last Update Submit

August 16, 2016

Conditions

Biological Availability

Keywords

carotenoidsphylloquinonetocopherolsvitamin A

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction

    0-9.5 hours postprandially

Interventions

Soybean oil in salad dressingOTHER

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile

You may not qualify if:

  • Cigarette smoking, frequent alcohol consumption
  • Use of vitamin/mineral supplements
  • Lactose intolerance
  • Known food allergies
  • Body mass index (BMI) 30 or higher
  • Eating disorder or restrained eating
  • Vegetarianism
  • Hyperlipidemia
  • Current or planned pregnancy
  • Use of hormonal contraceptives (affects chylomicron clearance); use of plant sterols or medications known to affect lipid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • White WS, Zhou Y, Crane A, Dixon P, Quadt F, Flendrig LM. Modeling the dose effects of soybean oil in salad dressing on carotenoid and fat-soluble vitamin bioavailability in salad vegetables. Am J Clin Nutr. 2017 Oct;106(4):1041-1051. doi: 10.3945/ajcn.117.153635. Epub 2017 Aug 16.

    PMID: 28814399DERIVED

MeSH Terms

Interventions

Soybean OilCondiments

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

April 1, 2009

Primary Completion

November 1, 2009

Study Completion

June 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-08