Shake It Up: Lipidomics of Lipoproteins and Diet

Sponsor

USDA Grand Forks Human Nutrition Research Center (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT04120220

Collaborator

(none)

Enrollment

Location

Arms

30.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight	Other: Heavy Cream Other: Soybean Oil	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Shake It Up: Lipidomics of Lipoproteins and Diet

Actual Study Start Date :

Nov 12, 2019

Actual Primary Completion Date :

May 20, 2022

Actual Study Completion Date :

May 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heavy Cream Participants will receive a meal containing 30 g of fat prepared with heavy cream.	Other: Heavy Cream Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.
Experimental: Soybean Oil Participants will receive a meal containing 30 g of fat prepared with soybean oil.	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.

Arm

Intervention/Treatment

Experimental: Heavy Cream

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

Other: Heavy Cream

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

Experimental: Soybean Oil

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

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.

Outcome Measures

Primary Outcome Measures

Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC) [0, 1, 2, 4, 6, 8 hours post meal intake]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota	United States	58203

Sponsors and Collaborators

USDA Grand Forks Human Nutrition Research Center

Investigators

Principal Investigator: Matthew Picklo, PhD, USDA Grand Forks Human Nutrition Research Center

Study Documents (Full-Text)

Informed Consent Form - Aug 23, 2021

More Information

Additional Information:

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Publications

None provided.

Responsible Party:

USDA Grand Forks Human Nutrition Research Center

ClinicalTrials.gov Identifier:

NCT04120220

Other Study ID Numbers:

GFHNRC511

First Posted:

Oct 9, 2019

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by USDA Grand Forks Human Nutrition Research Center

Normal weight

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Aug 4, 2022