Shake It Up: Lipidomics of Lipoproteins and Diet

NCT04120220 | Terminated

• 1 other identifier: GFHNRC511
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Normal weight

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Heavy Cream

EXPERIMENTAL

Participants will receive a meal containing 30 g of fat prepared with heavy cream.

Other: Heavy Cream

Soybean Oil

EXPERIMENTAL

Participants will receive a meal containing 30 g of fat prepared with soybean oil.

Other: Soybean Oil

Interventions

Heavy Cream OTHER

Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.

Heavy Cream

Soybean Oil OTHER

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

Soybean Oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal to overweight (BMI 18.0-29.9 kg/m\^2
• Willing to comply with the demands of the experimental protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

MeSH Terms

Conditions

Overweight

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Matthew Picklo, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: November 12, 2019
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)