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Pilot Study to Test Dietary Fat Delivery

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Insulin Resistance

Treatments

Other: high-fat diet

Study type

Observational

Funder types

Other

Identifiers

NCT02101996
1211238

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Lean/insulin sensitive (n=10, BMI ≤ 24 kg/m2 and glucose infusion > 4.0 mg/min))
  2. Overweight/obese insulin resistant (n=10, BMI 26-35 and glucose infusion < 4.0 mg/min)
  3. 30-50 years of age
  4. Men and pre-menopausal women

Exclusion criteria

  1. Insulin resistance is defined by insulin clamp as the rate of glucose infusion ≤ 4.0 mg/min.
  2. BMI over 35 kg/m2
  3. Abnormal thyroid function, kidney or liver disease
  4. Uncontrolled hypertension, or occasional or regular smoker, use of medications or supplements that interfere with lipid, protein, or carbohydrate metabolism
  5. Pregnancy (urine test), breast feeding an infant, or anemia
  6. Alcohol intake: Males >140 g/week, Females > 70 g/week.
  7. 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.
  8. Need to consume acetaminophen-containing medications on a regular basis.

Trial design

9 participants in 2 patient groups

Healthy
Description:
Not insulin resistant
Treatment:
Other: high-fat diet
Insulin resistant
Description:
Insulin resistant by an insulin clamp
Treatment:
Other: high-fat diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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