Shake It Up: Lipidomics of Lipoproteins and Diet

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.

Study Overview

• Status: Terminated
• Conditions: Overweight
• Intervention / Treatment: Other: Heavy Cream; Other: Soybean Oil

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Normal weight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: GFHNRC511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No