NCT02101996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

March 28, 2014

Last Update Submit

August 17, 2016

Conditions

Insulin Resistance

Keywords

stable isotopestriacylglycerol

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Healthy

Not insulin resistant

Other: high-fat diet

Insulin resistant

Insulin resistant by an insulin clamp

Other: high-fat diet

Interventions

high-fat dietOTHER

Subjects consume a high-fat diet for three weeks before the in-hospital stay.

HealthyInsulin resistant

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy and insulin resistant subjects.

You may qualify if:

  • 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)
  • years of age
  • Men and pre-menopausal women

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (2)

  • 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.

    PMID: 21820684BACKGROUND

  • 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.

    PMID: 22723441BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and muscle biopsy samples are kept in Dr. Parks' lab for further study analysis.

MeSH Terms

Conditions

Insulin Resistance

Interventions

Diet, High-Fat

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Elizabeth J Parks, PhD

    Univ of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 2, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

US(1)