Pilot Study to Test Dietary Fat Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

NCT01451970

Overweight/Obese Women

COMPLETED NA

Lipids and Insulin Sensitivity

NCT01466816

Obesity Insulin Resistance

COMPLETED NA

Short Chain Fatty Acid Metabolism and Energy Metabolism

NCT01826162

Type 2 Diabetes Mellitus Obesity

COMPLETED NA

Impact of a High Saturated Fat Diet on Fasted Systemic and White Adipose Tissue Inflammatory Responses

NCT03569189

Inflammation Obesity Inflammatory Response +1 more

COMPLETED NA

Effect of High Fat Diet on Muscle Metabolism

NCT02328235

Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

Not insulin resistant

high-fat diet

Intervention Type OTHER

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

Insulin resistant

Insulin resistant by an insulin clamp

high-fat diet

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high-fat diet

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes