Effect of High Fat Diet on Muscle Metabolism

NCT02328235 | Completed DMC

• 1 other identifier: 06-367
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Skeletal muscle burns a significant amount of the fat and sugar that circulates in the blood stream. Ideally, when sugar is elevated in the blood stream, the muscle will either use it to make new energy or store it for later use. Likewise, for fatty acids. Skeletal muscle of obese and diabetic humans has been shown to inadequately use either sugar or fatty acids when they increase in the blood stream, and this has been termed metabolic inflexibility. The cause of metabolic inflexibility is not known, but it is believed that eating more fat than the body needs for energy may be a contributing factor. Metabolic inflexibility in skeletal muscle is bad because if the muscle does not use the sugar or fat, it will be stored elsewhere in the body and potentially lead to obesity and the resistance to insulin. The investigators have performed a research study with nonobese, healthy humans during which we fed them a high fat diet for 5 days. Interesting, only 5 days of a high fat diet is sufficient to cause the skeletal muscle to become metabolically inflexible just like that observed in obese and diabetic humans. The investigators are proposing addition studies to feed healthy humans a high fat diet for 5 days in effort to better understand what causes metabolic flexibility. The investigators are speculating that a high fat diet causes the intestines to release a substance called endotoxin that causes muscle to become metabolically inflexible. The investigators will test this notion in our proposed studies.

Conditions

Diabetes

Keywords

skeletal muscle, metabolism, physiology

Outcome Measures

Primary Outcomes (1)

• Metabolic Flexibility measured ex vivo in skeletal muscle using radio labeled carbon isotopes

  Assess substrate handling ex vivo in skeletal muscle using radio labeled isotopes pre and post high fat diet

  1 day

Secondary Outcomes (1)

• Intestinal Permeability using a 4 sugar probe test and mass spectrometry

  24 hours

Study Arms (1)

High Saturated Fat Diet

EXPERIMENTAL

Subjects will receive a high fat diet for 5 day following a 2 week lead in diet. Measurements will be made pre-post high fat diet

Other: High Saturated Fat Diet

Interventions

High Saturated Fat Diet OTHER

Prior to the high fat diet and after baseline testing, subjects will be asked to eat a standard diet to "lead-in" to the high fat diet condition. The diet will contain 55% of calories as carbohydrate, 30% as fat, and 15% as protein. The high fat diet will contain 50-60% of calories as fat, 20-30% as carbohydrate, and 10-20% as protein. Subjects will be provided with all of their meals throughout the study.

High Saturated Fat Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, age 18-40 years; BMI between 20 and 30 kg/m2. Weight stable for previous 6 months (± 2.0kg).
• Sedentary to recreationally active (≤ 3 days, 20 min/day of walking type exercise, no planned exercise other than leisure walking for transportation purposes).
• Verbal and written informed consent
• non-smoking
• Approved for participation by Medical Director (Jose Rivero, M.D.)

You may not qualify if:

• \. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
• \. Family history of diabetes
• \. BMI \> 30 kg/m2, blood pressure \> 140/90 mmHg or antihypertensive medications, fasting glucose \> 100 mg/dl, LDL cholesterol \> 130 mg/dl, total cholesterol \> 200 mg/dl, triglycerides \> 250 mg/dl.
• \. Verbal and written informed consent
• \. Smoking, alcohol consumption \> 2 servings/d, or taking medications (including but not limited to statins or other drugs with anti-inflammatory actions) or antioxidant vitamins or supplements, or know to affect carbohydrate or lipid metabolism.
• \. Total daily dietary fat consumption ≥ 35% and/or saturated fat consumption of ≥ 15%.

Sponsors & Collaborators

• Kevin Davy: lead
• American Diabetes Association: collaborator

Study Sites (1)

Virginia Polytechnic and State University

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin P Davy, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 9, 2018
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)