Shake It Up: Lipidomics of Lipoproteins and Diet | NCT04120220

Studies
Shake It Up: Lipidomics of Lipoproteins and Diet

NCT04120220

Sponsor

USDA Grand Forks Human Nutrition Research Center

Status

Terminated

Last Update Posted

Aug 4, 2022Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Overweight

Interventions

Heavy Cream
Soybean Oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI will be retiring from the Center. Research will not continue with a new PI.

Expanded Access Info

Start Date

Nov 12, 2019Actual

Primary Completion Date

May 20, 2022Actual

Completion Date

May 20, 2022Actual

First Submitted Date

Oct 7, 2019

First Submission Date that Met QC Criteria

Oct 7, 2019

First Posted Date

Oct 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Picklo, PhD	USDA Grand Forks Human Nutrition Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USDA Grand Forks Human Nutrition Research Center		Grand Forks	North Dakota	58203	United States

Label	URL
Grand Forks Human Nutrition Research Center Current Nutrition Studies	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids