Shake It Up: Lipidomics of Lipoproteins and Diet

Overweight Clinical Trial

Official title:

Shake It Up: Lipidomics of Lipoproteins and Diet

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04120220
• Other study ID #: GFHNRC511
• Status: Terminated
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: May 20, 2022

Study information

• Verified date: August 2022
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies