NCT01006174

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

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

October 30, 2009

Last Update Submit

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

EXPERIMENTAL

Subjects will be assigned to consume 3 grams soybean oil, 8 grams canola oil, and 20 grams butter that is added to a salad.

Other: Soybean OilOther: Canola OilOther: Butter

B

EXPERIMENTAL

Subjects will be assigned to consume 8 grams soybean oil, 20 grams canola oil, and 3 grams butter that is added to a salad.

Other: Soybean OilOther: Canola OilOther: Butter

C

EXPERIMENTAL

Subjects will be assigned to consume 20 grams soybean oil, 3 grams canola oil, and 8 grams butter that is added to a salad.

Other: Soybean OilOther: Canola OilOther: Butter

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.

ABC

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.

ABC
ButterOTHER

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.

ABC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
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.
  • 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

Location

MeSH Terms

Interventions

Soybean OilRapeseed OilButter

Intervention Hierarchy (Ancestors)

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

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

Locations