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Pilot Study to Test Dietary Fat Delivery

Pilot Study to Test Dietary Fat Delivery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02101996
Enrollment
9
Registered
2014-04-02
Start date
2014-06-30
Completion date
2016-08-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

stable isotopes, triacylglycerol

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.

Interventions

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

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Meal fat absorption and storageChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026