Pilot Study to Test Dietary Fat Delivery

Completed

• Conditions: Insulin Resistance
• Interventions: Other: high-fat diet

• Registration Number: NCT02101996
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-02
• Study Start: 2014-06
• Primary Completion: 2016-03
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin resistant	high-fat diet	Insulin resistant by an insulin clamp
Healthy	high-fat diet	Not insulin resistant

Primary Outcome Measures

Name	Time	Method
Meal fat absorption and storage	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.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States