Insulin ResistanceNCT03863431
The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
A study testing High-fat diet and High-carbohydrate diet in people with Insulin Resistance and Type 2 Diabetes, run by Loughborough University at 1 site in United Kingdom.
Trial summary
This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity. Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes, Glucose Metabolism Disorders
- What is being tested?
- High-fat diet and High-carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2019to Jun 2021
- 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
- 18-40 years
- BMI = 18.5-29.9 kg/m2
- Male or female
- Physically active (> 3 x 30 min moderate exercise per week)
- Non-smoker (including the use of vaporisers and e-cigarettes)
- Healthy (determined by the School's standard health questionnaire)
- No cardiometabolic or inflammatory illness
Who cannot join
- Outside of age-range
- Outside BMI range
- Inactive (< 3 x 30 min moderate exercise per week)
- Smoker
- Taking medication
- History of cardiometabolic or inflammatory illness
Show all 12Show fewer
- Vegetarian/ vegan (as the high-fat diet is based on animal fats)
- Other dietary restrictions which prevent consumption of the experimental diet
- Consumption of probiotics within last 3 months (these influence the gut microbiota)
- Participation in another clinical trial
- Those with known or suspected food intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
Trial locations and contacts
1 site in 1 country.
Zachary Lockhead, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
School of Sport, Exercise and Health Sciences
Loughborough, Leicestershire, LE11 3TU
Carl Hulston, PhD
About this study
This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.
Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test [OGTT]).
- Being tested
- High-fat diet, High-carbohydrate diet
- Keywords
- High-fat diets, High-carbohydrate diets, Glycaemic control
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat dietOther
Participants will consume a high fat diet for 14 days with approximately 65% of energy from fat. The diet will also provide an energy excess, at 130% of energy requirements.
Participants will be provided with all of their meals and snacks throughout the study.
High-carbohydrate dietOther
Participants will consume a high fat diet for 14 days with approximately 70% of energy from carbohydrate. The diet will also provide an energy excess, at 130% of energy requirements.
Participants will be provided with all of their meals and snacks throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| High-fat diet | Active comparator | Participants will consume a diet rich in fat (approximately 65% of total energy) and low in carbohydrate for 14 days.
Measurements will be made at 0, 7 and 14 days. Receives: Other: High-fat diet |
| High-carbohydrate diet | Active comparator | Participants will consume a diet rich in carbohydrate (approximately 70% of total energy) and low in fat for 14 days.
Measurements will be made at 0, 7 and 14 days. Receives: Other: High-carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body insulin sensitivity index
Assessed by oral glucose tolerance test
Measured: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14
Secondary outcomes (6)
Body Mass Index
Calculated from height and weight
Measured: Day 0, Day 7, Day 14
Fasting plasma glucose concentration
Measured in fasting plasma sample by spectrophotometric assay
Measured: Day 0, Day 7, Day 14
Fasting serum insulin concentration
Measured in fasting serum sample by ELISA
Measured: Day 0, Day 7, Day 14
Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)
Measured in fasting plasma sample by spectrophotometric assay
Measured: Day 0, Day 7, Day 14
Indirect calorimetry
Measured from expired gas samples
Measured: Day 0, Day 7, Day 14
Subjective appetite ratings
Measured from visual analogue scale appetite questionnaires
Measured: Day 0, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start22 May 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Hulston, Loughborough University
- Investigators
- Carl Hulston, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863431
- Sponsor's protocol ID
- R18-P222
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT03863431
- Acronym / sponsor ID
- R18-P222
- Keywords
- High-fat diets, High-carbohydrate diets, Glycaemic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 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 will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.
Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test [OGTT]).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fat diet | Active comparator | Other: High-fat dietParticipants will consume a diet rich in fat (approximately 65% of total energy) and low in carbohydrate for 14 days. Measurements will be made at 0, 7 and 14 days. |
| High-carbohydrate diet | Active comparator | Other: High-carbohydrate dietParticipants will consume a diet rich in carbohydrate (approximately 70% of total energy) and low in fat for 14 days. Measurements will be made at 0, 7 and 14 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-40 years
- BMI = 18.5-29.9 kg/m2
- Male or female
- Physically active (> 3 x 30 min moderate exercise per week)
- Non-smoker (including the use of vaporisers and e-cigarettes)
Key exclusion criteria (12 listed)
- Outside of age-range
- Outside BMI range
- Inactive (< 3 x 30 min moderate exercise per week)
- Smoker
- Taking medication
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 dietParticipants will consume a high fat diet for 14 days with approximately 65% of energy from fat. The diet will also provide an energy excess, at 130% of energy requirements. Participants will be provided with all of their meals and snacks throughout the study. | Other | High-fat diet |
| High-carbohydrate dietParticipants will consume a high fat diet for 14 days with approximately 70% of energy from carbohydrate. The diet will also provide an energy excess, at 130% of energy requirements. Participants will be provided with all of their meals and snacks throughout the study. | Other | High-carbohydrate diet |
Primary outcome
Whole-body insulin sensitivity index
Time frame: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14
Assessed by oral glucose tolerance test
6 secondary outcomes
Body Mass Index
Time frame: Day 0, Day 7, Day 14
Fasting plasma glucose concentration
Time frame: Day 0, Day 7, Day 14
Fasting serum insulin concentration
Time frame: Day 0, Day 7, Day 14
Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)
Time frame: Day 0, Day 7, Day 14
Indirect calorimetry
Time frame: Day 0, Day 7, Day 14
Subjective appetite ratings
Time frame: Day 0, Day 7, Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
Zachary Lockhead, MSc contact
Carl Hulston, PhD principal investigator
Loughborough 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-fat diet and High-carbohydrate diet in people with Insulin Resistance and Type 2 Diabetes, run by Loughborough University at 1 site in United Kingdom.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl Hulston, PhD (+44 (0)1509 226449, c.j.hulston@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body insulin sensitivity index (time frame: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14). 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 24 Feb 2021.