Shake It Up: Lipidomics of Lipoproteins and Diet

Not Applicable

Terminated

• Conditions: Overweight
• Interventions: Other: Soybean Oil; Other: Heavy Cream

• Registration Number: NCT04120220
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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.

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-11-12
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soybean Oil	Soybean Oil	Participants will receive a meal containing 30 g of fat prepared with soybean oil.
Heavy Cream	Heavy Cream	Participants will receive a meal containing 30 g of fat prepared with heavy cream.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

USDA Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States