DiabetesNCT02328235
Effect of High Fat Diet on Muscle Metabolism
A study testing High Saturated Fat Diet in people with Diabetes, run by Kevin Davy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- High Saturated Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
Who cannot join
- 1. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
- 2. Family history of diabetes
- 3. 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.
- 4. Verbal and written informed consent
- 4. 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.
- 5. Total daily dietary fat consumption ≥ 35% and/or saturated fat consumption of ≥ 15%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic and State University
Blacksburg, Virginia, 24061
About this study
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.
Read the detailed description
Objective: To discern the potential mechanism(s) by which high saturated fat feeding disrupts normal skeletal muscle metabolism. Our working hypothesis is that high saturated fat feeding increases gut permeability and blood endotoxin, which elicits pro-inflammatory signaling in skeletal muscle and alters the normal adaptive response to a meal. Preliminary evidence using a model of acute (5 days), high saturated fat feeding, isocaloric to habitual intake, in healthy, non-obese humans is presented herein to support this hypothesis.
Background: The inability for skeletal muscle to adapt fuel oxidation to fuel availability is termed metabolic inflexibility, a well characterized feature of disease states such as obesity, metabolic syndrome, and type 2 diabetes (T2D). The mechanism(s) responsible for skeletal muscle metabolic inflexibility are not known. Recently, there has been growing interest in the role of gut permeability and blood endotoxin in the pathology of metabolic derangements associated with obesity and T2D. Rodent studies have revealed direct links between the gut microbiome and metabolic disease, as well as associations between elevated blood endotoxin and metabolic dysregulation, both at the whole body and tissue level. High fat feeding in rodents is known to elicit elevated levels of blood endotoxin, a phenomenon that is termed metabolic endotoxemia. In humans, obesity and T2D are associated with increased blood endotoxin and single meals have been shown to elevate blood endotoxin, but to date, there is no evidence in humans that high fat feeding results in metabolic endotoxemia. Moreover, there are no established links between gut permeability, metabolic endotoxemia, and skeletal muscle metabolic function in humans.
Approach. We are proposing to utilize a model of acute high fat feeding in healthy humans to study the interplay between gut function, blood endotoxin, and skeletal muscle pro-inflammatory signaling and metabolic adaptability. We will employ a two-week lead-in period, during which research participants will be fed prepared meals that are isocaloric to their habitual diet, followed by five days of high saturated fat feeding. The high saturated fat feeding period will consist of prepared meals that are isocaloric to habitual diet with a macronutrient composition of 50% fat (45% of which will be saturated fat), 35% carbohydrate, and 15% protein. Studying healthy, nonobese humans in this context is an innovative approach on two levels: 1) any confounding influences associated with metabolic disease (obesity, diabetes, or metabolic syndrome) are eliminated, e.g., insulin resistance, hyperlipidemia, impaired gut function, pre-existing metabolic dysfunction and inflammatory tone; and 2) the isocaloric feeding design negates the confounding influence of a positive energy balance and allows us to specifically examine the effects of acutely increasing dietary saturated fat.
- Conditions
- Diabetes
- Being tested
- High Saturated Fat Diet
- Keywords
- skeletal muscle, metabolism, physiology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Saturated Fat DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: High Saturated Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Intestinal Permeability using a 4 sugar probe test and mass spectrometry
Assess intestinal permeability with a variety of insoluble sugars and their level of excretion in the urine with mass spectrometry pre and post high fat diet
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2017
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Davy
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor-investigator, Kevin Davy, Virginia Polytechnic Institute and State University
- Investigators
- Kevin P Davy, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328235
- Sponsor's protocol ID
- 06-367
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2014
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Fat Diet on Muscle Metabolism
- ClinicalTrials.gov ID
- NCT02328235
- Acronym / sponsor ID
- 06-367
- Conditions
- Diabetes
- Keywords
- skeletal muscle, metabolism, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kevin DavyUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To discern the potential mechanism(s) by which high saturated fat feeding disrupts normal skeletal muscle metabolism. Our working hypothesis is that high saturated fat feeding increases gut permeability and blood endotoxin, which elicits pro-inflammatory signaling in skeletal muscle and alters the normal adaptive response to a meal. Preliminary evidence using a model of acute (5 days), high saturated fat feeding, isocaloric to habitual intake, in healthy, non-obese humans is presented herein to support this hypothesis.
Background: The inability for skeletal muscle to adapt fuel oxidation to fuel availability is termed metabolic inflexibility, a well characterized feature of disease states such as obesity, metabolic syndrome, and type 2 diabetes (T2D). The mechanism(s) responsible for skeletal muscle metabolic inflexibility are not known. Recently, there has been growing interest in the role of gut permeability and blood endotoxin in the pathology of metabolic derangements associated with obesity and T2D. Rodent studies have revealed direct links between the gut microbiome and metabolic disease, as well as associations between elevated blood endotoxin and metabolic dysregulation, both at the whole body and tissue level. High fat feeding in rodents is known to elicit elevated levels of blood endotoxin, a phenomenon that is termed metabolic endotoxemia. In humans, obesity and T2D are associated with increased blood endotoxin and single meals have been shown to elevate blood endotoxin, but to date, there is no evidence in humans that high fat feeding results in metabolic endotoxemia. Moreover, there are no established links between gut permeability, metabolic endotoxemia, and skeletal muscle metabolic function in humans.
Approach. We are proposing to utilize a model of acute high fat feeding in healthy humans to study the interplay between gut function, blood endotoxin, and skeletal muscle pro-inflammatory signaling and metabolic adaptability. We will employ a two-week lead-in period, during which research participants will be fed prepared meals that are isocaloric to their habitual diet, followed by five days of high saturated fat feeding. The high saturated fat feeding period will consist of prepared meals that are isocaloric to habitual diet with a macronutrient composition of 50% fat (45% of which will be saturated fat), 35% carbohydrate, and 15% protein. Studying healthy, nonobese humans in this context is an innovative approach on two levels: 1) any confounding influences associated with metabolic disease (obesity, diabetes, or metabolic syndrome) are eliminated, e.g., insulin resistance, hyperlipidemia, impaired gut function, pre-existing metabolic dysfunction and inflammatory tone; and 2) the isocaloric feeding design negates the confounding influence of a positive energy balance and allows us to specifically examine the effects of acutely increasing dietary saturated fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Saturated Fat Diet | Experimental | Other: High Saturated Fat DietSubjects 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (6 listed)
- 1. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
- 2. Family history of diabetes
- 3. 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.
- 4. Verbal and written informed consent
- 4. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Saturated Fat DietPrior 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. | Other | High Saturated Fat Diet |
Primary outcome
Metabolic Flexibility measured ex vivo in skeletal muscle using radio labeled carbon isotopes
Time frame: 1 day
Assess substrate handling ex vivo in skeletal muscle using radio labeled isotopes pre and post high fat diet
1 secondary outcome
Intestinal Permeability using a 4 sugar probe test and mass spectrometry
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin P Davy, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Saturated Fat Diet in people with Diabetes, run by Kevin Davy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Flexibility measured ex vivo in skeletal muscle using radio labeled carbon isotopes (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.