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OpenTrials
Completed

NCT Number: NCT02101996

Pilot Study to Test Dietary Fat Delivery

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

high-fat diet

Other

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

Primary outcomes

  1. Meal fat absorption and storage

    Time frame: Change in meal fat concentration in body tissues 8 h after two high-fat meals.

    Meal fat absorption and storage are measured using stable isotopes administration into sequential meals (breakfast and lunch). Analysis of plasma and muscle samples.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2014
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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