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Shake It Up: Lipidomics of Lipoproteins and Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120220
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Picklo, 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.

Condition or disease Intervention/treatment Phase
Overweight Other: Heavy Cream Other: Soybean Oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 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 : November 12, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

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.




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120220


Contacts
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Contact: Matthew Picklo, PhD 701-795-8380 matthew.picklo@usda.gov

Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58203
Contact: Angela J Scheett, MPH, RD    701-795-8386    angela.scheett@usda.gov   
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
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Principal Investigator: Matthew Picklo, PhD USDA Grand Forks Human Nutrition Research Center

Additional Information:
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Responsible Party: Matthew Picklo, Supervisory Research Physiologist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT04120220    
Other Study ID Numbers: GFHNRC511
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Picklo, USDA Grand Forks Human Nutrition Research Center:
Normal weight
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms