Pilot Study to Test Dietary Fat Delivery

Insulin Resistance Clinical Trial

Official title:

Pilot Study to Test Dietary Fat Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101996
• Other study ID #: 1211238
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: August 17, 2016
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes