Pilot Study to Test Dietary Fat Delivery | NCT02101996

Studies
Pilot Study to Test Dietary Fat Delivery

NCT02101996

Sponsor

University of Missouri-Columbia

Status

Completed

Last Update Posted

Aug 19, 2016Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Insulin Resistance

Interventions

high-fat diet

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 1, 2014

First Posted Date

Apr 2, 2014Estimated

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 17, 2016

Last Update Posted Date

Aug 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 average American diet consumed by a significant proportion of the adult population, supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found in the blood, along with markers of poor muscle metabolism.

Both fats and amino acids are processed by the same metabolic pathways in muscle, and the investigators hypothesize that meals with greater amounts of saturated fat slow muscle metabolism. A better understanding of the interaction of these to metabolites will allow for the development of future medications to treat muscle loss in sick individuals and the elderly.

Detailed Description

This study includes two parts, a baseline study and a three-week dietary study. The baseline study will be performed to test how the body absorbs and stores meal fat after a meal. In the three-week dietary study, the subjects will consume only the meals provided by the investigators for three weeks before the tests, and then participate in a hospital stay. The three-week dietary study is to test the chronic effect of a high fat diet on how body absorbs and stores the fat.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Not insulin resistant	Other: high-fat diet
Insulin resistant		Insulin resistant by an insulin clamp	Other: high-fat diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-fat diet	Other	Subjects consume a high-fat diet for three weeks before the in-hospital stay.	Healthy Insulin resistant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meal fat absorption and storage	Meal fat absorption and storage are measured using stable isotopes administration into sequential meals (breakfast and lunch). Analysis of plasma and muscle samples.	Change in meal fat concentration in body tissues 8 h after two high-fat meals.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lean/insulin sensitive (n=10, BMI ≤ 24 kg/m2 and glucose infusion > 4.0 mg/min))
Overweight/obese insulin resistant (n=10, BMI 26-35 and glucose infusion < 4.0 mg/min)
30-50 years of age
Men and pre-menopausal women

Exclusion Criteria:

Insulin resistance is defined by insulin clamp as the rate of glucose infusion ≤ 4.0 mg/min.
BMI over 35 kg/m2
Abnormal thyroid function, kidney or liver disease
Uncontrolled hypertension, or occasional or regular smoker, use of medications or supplements that interfere with lipid, protein, or carbohydrate metabolism
Pregnancy (urine test), breast feeding an infant, or anemia
Alcohol intake: Males >140 g/week, Females > 70 g/week.
Fasting plasma triglycerides >300 mg/dL. Extreme hypertriglyceridemia could be due to either elevations in very low-density lipoproteins or chylomicrons, either of which would impair our ability to resolve dietary metabolic processes.
Need to consume acetaminophen-containing medications on a regular basis.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Healthy and insulin resistant subjects.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth J Parks, PhD	Univ of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri		Columbia	Missouri	65212	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21820684	Background	Ramos-Roman MA, Sweetman L, Valdez MJ, Parks EJ. Postprandial changes in plasma acylcarnitine concentrations as markers of fatty acid flux in overweight and obesity. Metabolism. 2012 Feb;61(2):202-12. doi: 10.1016/j.metabol.2011.06.008. Epub 2011 Aug 5.
22723441	Background	Ramos-Roman MA, Lapidot SA, Phair RD, Parks EJ. Insulin activation of plasma nonesterified fatty acid uptake in metabolic syndrome. Arterioscler Thromb Vasc Biol. 2012 Aug;32(8):1799-808. doi: 10.1161/ATVBAHA.112.250019. Epub 2012 Jun 21.

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena