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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04120220
Other study ID # GFHNRC511
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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