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Shake It Up: Lipidomics of Lipoproteins and Diet

Primary Purpose

Overweight

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Heavy Cream

Soybean Oil

About this trial

This is an interventional basic science trial for Overweight focused on measuring Normal weight

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Heavy Cream

Soybean Oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)

Secondary Outcome Measures

Full Information

NCT ID

NCT04120220

First Posted

October 7, 2019

Last Updated

August 1, 2022

Sponsor

USDA Grand Forks Human Nutrition Research Center

1. Study Identification

Unique Protocol Identification Number

NCT04120220

Brief Title

Shake It Up: Lipidomics of Lipoproteins and Diet

Official Title

Shake It Up: Lipidomics of Lipoproteins and Diet

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

PI will be retiring from the Center. Research will not continue with a new PI.

Study Start Date

November 12, 2019 (Actual)

Primary Completion Date

May 20, 2022 (Actual)

Study Completion Date

May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

Keywords

Normal weight

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heavy Cream

Arm Type

Experimental

Arm Description

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

Arm Title

Soybean Oil

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Heavy Cream

Intervention Description

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

Intervention Name(s)

Soybean Oil

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)

Time Frame

0, 1, 2, 4, 6, 8 hours post meal intake

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Picklo, PhD

Organizational Affiliation

USDA Grand Forks Human Nutrition Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

USDA Grand Forks Human Nutrition Research Center

City

Grand Forks

State/Province

North Dakota

ZIP/Postal Code

58203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Learn more about this trial

Shake It Up: Lipidomics of Lipoproteins and Diet

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