Shake It Up: Lipidomics of Lipoproteins and Diet

NCT ID: NCT04120220

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2022-05-20

Brief Summary

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The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.

Detailed Description

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The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Heavy Cream

Participants will receive a meal containing 30 g of fat prepared with heavy cream.

Group Type EXPERIMENTAL

Heavy Cream

Intervention Type OTHER

Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.

Soybean Oil

Participants will receive a meal containing 30 g of fat prepared with soybean oil.

Group Type EXPERIMENTAL

Soybean Oil

Intervention Type OTHER

Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil.

Interventions

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Heavy Cream

Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.

Intervention Type OTHER

Soybean Oil

Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal to overweight (BMI 18.0-29.9 kg/m\^2
* Willing to comply with the demands of the experimental protocol

Exclusion Criteria

* Inability to provide consent
* Have fasting blood glucose \<60 mg/dL or \>126 mg/dL
* Have fasting blood cholesterol \>300 mg/dL
* Have fasting blood triglyceride \<100 mg/dL or \>300 mg/dL
* Have uncontrolled hypertension (blood pressure \>140/90 mm Hg)
* Take prescription medications for blood sugar or lipid management or anti-inflammatory steroids (e.g. cortisone)
* Over the counter use of supplements (fish oil, flax, plant sterol or sterol esters) and unwilling to discontinue use for 6 weeks prior to study initiation
* Have a history of an eating disorder, unusual dietary pattern (extreme nutrient or food group restriction; erratic meals due to shift work, etc.)
* Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
* Have cancer
* Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes/vaping in the past 6 weeks
* Have alcohol, anabolic steroids, or other substance abuse issues
* Consume more than 3 alcoholic drinks/week
* Are lactose intolerant or have an allergy to dairy foods
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Picklo, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

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USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Other Identifiers

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GFHNRC511

Identifier Type: -

Identifier Source: org_study_id

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