HealthyNCT03879187
Molecular and Hormonal Responses to Diet-Induced Insulin Resistance
A study testing High-fat, high-energy diet in people with Healthy, run by Loughborough University.
Trial summary
This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-fat, high-energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 22 May 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40 years
- Physically active
- Non-smoker
- Not taking any medication known to interfere with the study
- No history of cardiovascular disease or diabetes
- Weight stable for the last 6 months
Who cannot join
- Outside of age range
- Sedentary
- Smoker
- Taking medication known to interfere with the study
- History of cardiovascular disease or diabetes
- Unstable weight within last 6 months
About this study
This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals.
Read the detailed description
Fifteen healthy, young individuals underwent metabolic testing before and after 7 days of high-fat overfeeding. We determined whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function. Stable isotope tracers were used to assess the rate of appearance of glucose from the gut, liver glucose output and whole-body glucose disposal. Insulin signalling was determined by Western blotting of skeletal muscle tissue. Microvascular function was assessed through the use of quantitative immunofluorescence microscopy. These measurements were performed both postabsorptively and following the ingestion of 50 grams of glucose + 15 grams of protein.
- Conditions
- Healthy
- Being tested
- High-fat, high-energy diet
- Keywords
- High-fat diet, Insulin, Glucose, Muscle, eNOS, Isotopes
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat, high-energy dietDietary supplement
Participants consumed a diet that was high in fat and high in energy
| Study group | Role | What they receive |
|---|---|---|
| High-fat diet | Experimental | Participants underwent a 7 day high-fat, high-energy diet intervention with metabolic measurements before and after Receives: Dietary Supplement: High-fat, high-energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose concentration
Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Glucose was reported as mmol/L.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Change in insulin concentration
Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Insulin was reported as pmol/L.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Change in glucose kinetics (i.e., rate of appearance and disappearance) assessed using isotope tracers
Glucose kinetics were assessed the day before and the day after the 7 day high-fat diet. Data expressed as umol/kg/min.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Change in skeletal muscle insulin signalling
AKT and AS160 phosphorylation was determined by Western blotting of skeletal muscle. Data are expressed as arbitrary units.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Change in markers of microvascular function
endothelial nitric oxide synthase was determined in terminal arterioles by quantitative immunofluorescence microscopy that was performed on sections of skeletal muscle tissue. Data presented as arbitrary units.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Secondary outcomes (1)
Change intramuscular triglyceride content
Intramuscular triglyceride content was determined by quantitative immunofluorescence microscopy that was performed on sections of skeletal muscle tissue. Data presented as arbitrary units.
Measured: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start2 Mar 2015
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Model description
- 15 healthy individuals were assessed before and after consuming a high-fat, high-energy diet for 7 days.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Hulston, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879187
- Sponsor's protocol ID
- R13-P171
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parry SA, Turner MC, Woods RM, James LJ, Ferguson RA, Cocks M, Whytock KL, Strauss JA, Shepherd SO, Wagenmakers AJM, van Hall G, Hulston CJ. High-Fat Overfeeding Impairs Peripheral Glucose Metabolism and Muscle Microvascular eNOS Ser1177 Phosphorylation. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz018. doi: 10.1210/clinem/dgz018.
PubMed 31513265
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Hormonal Responses to Diet-Induced Insulin Resistance
- ClinicalTrials.gov ID
- NCT03879187
- Acronym / sponsor ID
- R13-P171
- Conditions
- Healthy
- Keywords
- High-fat diet, Insulin, Glucose, Muscle, eNOS, Isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 18 Mar 2019 (actual)
- 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.
This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function in 15 healthy young individuals.
Detailed description
Fifteen healthy, young individuals underwent metabolic testing before and after 7 days of high-fat overfeeding. We determined whole-body glycaemic control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle microvascular function. Stable isotope tracers were used to assess the rate of appearance of glucose from the gut, liver glucose output and whole-body glucose disposal. Insulin signalling was determined by Western blotting of skeletal muscle tissue. Microvascular function was assessed through the use of quantitative immunofluorescence microscopy. These measurements were performed both postabsorptively and following the ingestion of 50 grams of glucose + 15 grams of protein.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 healthy individuals were assessed before and after consuming a high-fat, high-energy diet for 7 days.
| Arm | Type | Receives |
|---|---|---|
| High-fat diet | Experimental | Dietary Supplement: High-fat, high-energy dietParticipants underwent a 7 day high-fat, high-energy diet intervention with metabolic measurements before and after |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 40 years
- Physically active
- Non-smoker
- Not taking any medication known to interfere with the study
- No history of cardiovascular disease or diabetes
Key exclusion criteria (6 listed)
- Outside of age range
- Sedentary
- Smoker
- Taking medication known to interfere with the study
- History of cardiovascular disease or diabetes
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-fat, high-energy dietParticipants consumed a diet that was high in fat and high in energy | Dietary supplement | High-fat diet |
Primary outcome
Change in glucose concentration
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Glucose was reported as mmol/L.
Change in insulin concentration
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Venous blood samples were obtained the day before and the day after the 7 day high-fat diet. Insulin was reported as pmol/L.
Change in glucose kinetics (i.e., rate of appearance and disappearance) assessed using isotope tracers
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
Glucose kinetics were assessed the day before and the day after the 7 day high-fat diet. Data expressed as umol/kg/min.
Change in skeletal muscle insulin signalling
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
AKT and AS160 phosphorylation was determined by Western blotting of skeletal muscle. Data are expressed as arbitrary units.
Change in markers of microvascular function
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
endothelial nitric oxide synthase was determined in terminal arterioles by quantitative immunofluorescence microscopy that was performed on sections of skeletal muscle tissue. Data presented as arbitrary units.
1 secondary outcome
Change intramuscular triglyceride content
Time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)
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 18 Mar 2019.
- Derived from this study: PubMed 31513265Parry SA, Turner MC, Woods RM, James LJ, Ferguson RA, Cocks M, Whytock KL, Strauss JA, Shepherd SO, Wagenmakers AJM, van Hall G, Hulston CJ. High-Fat Overfeeding Impairs Peripheral Glucose Metabolism and Muscle Microvascular eNOS Ser1177 Phosphorylation. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz018. doi: 10.1210/clinem/dgz018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat, high-energy diet in people with Healthy, run by Loughborough University.
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 6 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in glucose concentration (time frame: Immediately before and after the 7 day high-fat diet (i.e., measurements were made 7 days apart)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879187, which also lists 1 linked publication.
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 18 Mar 2019.