Glucose Tolerance ImpairedAFDRNCT05906342
Dose Response Relationship Between Fat Ingestion and Metabolism
A study testing 20% fat meal, 40% fat meal and 60% fat meal in people with Glucose Tolerance Impaired, run by McMaster University at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. The main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance Impaired
- What is being tested?
- 20% fat meal, 40% fat meal and 60% fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 30 Apr 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 30.0 kg/m2
- Weight stable for the past 6 months (± 2kg)
- VO2max values within a below average to above average range (38-50 mL/kg and 35-47 mL/kg for 18-25 year old males and females respectively. 35-48 mL/kg and 34-45 mL/kg for 26-35 year old males and females respectively)
- Fasting blood glucose <6.0 mM
- Resting blood pressure <140/90 mmHg
- Taking second generation oral contraceptives (females only)
Who cannot join
- Smoking
- Diabetes, cancer, or other metabolic disorders
- Cardiac or gastrointestinal problems
- Infectious disease
- Barium swallow or nuclear medicine scan in the previous 3 weeks
- Follow a strict vegan diet
- Pregnant or breastfeeding (females only)
- Diagnosis of polycystic ovary syndrome (females only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Acute Fat Ingestion on Glucose Metabolism in Young Healthy Adults: a Dose Response Study
The goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. The main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in hunger. Participant will consume four meals consisting of either 20, 40, 60, or 80% energy from fat.
Read the detailed description
The long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. Similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. Comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. Therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.
- Conditions
- Glucose Tolerance Impaired
- Being tested
- 20% fat meal, 40% fat meal, 60% fat meal, 80% fat meal
- Keywords
- High-fat, Glucose, Insulin, Metabolism, Nutrition
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% fat mealOther
Provided to participants once throughout duration of study, contains 20% fat
40% fat mealOther
Provided to participants once throughout duration of study, contains 40% fat
60% fat mealOther
Provided to participants once throughout duration of study, contains 60% fat
80% fat mealOther
Provided to participants once throughout duration of study, contains 80% fat
| Study group | Role | What they receive |
|---|---|---|
| 20% fat meal | Experimental | This meal will contain 15 kcal/kg of body weight and consist of 20% fat, 65% carbohydrates, and 15% protein. Receives: Other: 20% fat meal |
| 40% fat meal | Experimental | This meal will contain 15 kcal/kg of body weight and consist of 40% fat, 45% carbohydrates, and 15% protein. Receives: Other: 40% fat meal |
| 60% fat meal | Experimental | This meal will contain 15 kcal/kg of body weight and consist of 60% fat, 25% carbohydrates, and 15% protein. Receives: Other: 60% fat meal |
| 80% fat meal | Experimental | This meal will contain 15 kcal/kg of body weight and consist of 80% fat, 5% carbohydrates, and 15% protein. Receives: Other: 80% fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption
Measured: Two hours (taking place following the 4-hour postprandial period)
Secondary outcomes (6)
Glucose and lipid metabolites
Postprandial availability of glucose (mM)
Measured: During the 4-hour postprandial period
Glucose and lipid metabolites
Postprandial availability of insulin (µIU/mL)
Measured: During the 4-hour postprandial period
Glucose and lipid metabolites
Postprandial availability of total cholesterol (mmol/L)
Measured: During the 4-hour postprandial period
Glucose and lipid metabolites
Postprandial availability of low-density lipoprotein (mmol/L)
Measured: During the 4-hour postprandial period
Glucose and lipid metabolites
Postprandial availability of high-density lipoprotein (mmol/L)
Measured: During the 4-hour postprandial period
Glucose and lipid metabolites
Postprandial availability of non-esterified fatty acids (mmol/L)
Measured: During the 4-hour postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Tolerance ImpairedStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Each participant will be required to consume four breakfast meals (containing 20, 40, 60, or 80% energy from fat) in a randomized order with a washout period between meals
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Bell, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906342
- Sponsor's protocol ID
- 16153
- Acronym
- AFDR
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Acute Fat Ingestion on Glucose Metabolism in Young Healthy Adults: a Dose Response Study
- ClinicalTrials.gov ID
- NCT05906342
- Acronym / sponsor ID
- AFDR / 16153
- Conditions
- Glucose Tolerance Impaired
- Keywords
- High-fat, Glucose, Insulin, Metabolism, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 Jun 2023 (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.
The goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. The main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in hunger. Participant will consume four meals consisting of either 20, 40, 60, or 80% energy from fat.
Detailed description
The long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. Similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. Comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. Therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Each participant will be required to consume four breakfast meals (containing 20, 40, 60, or 80% energy from fat) in a randomized order with a washout period between meals
| Arm | Type | Receives |
|---|---|---|
| 20% fat meal | Experimental | Other: 20% fat mealThis meal will contain 15 kcal/kg of body weight and consist of 20% fat, 65% carbohydrates, and 15% protein. |
| 40% fat meal | Experimental | Other: 40% fat mealThis meal will contain 15 kcal/kg of body weight and consist of 40% fat, 45% carbohydrates, and 15% protein. |
| 60% fat meal | Experimental | Other: 60% fat mealThis meal will contain 15 kcal/kg of body weight and consist of 60% fat, 25% carbohydrates, and 15% protein. |
| 80% fat meal | Experimental | Other: 80% fat mealThis meal will contain 15 kcal/kg of body weight and consist of 80% fat, 5% carbohydrates, and 15% protein. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI between 18.5 and 30.0 kg/m2
- Weight stable for the past 6 months (± 2kg)
- VO2max values within a below average to above average range (38-50 mL/kg and 35-47 mL/kg for 18-25 year old males and females respectively. 35-48 mL/kg and 34-45 mL/kg for 26-35 year old males and females respectively)
- Fasting blood glucose <6.0 mM
- Resting blood pressure <140/90 mmHg
Key exclusion criteria (8 listed)
- Smoking
- Diabetes, cancer, or other metabolic disorders
- Cardiac or gastrointestinal problems
- Infectious disease
- Barium swallow or nuclear medicine scan in the previous 3 weeks
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 |
|---|---|---|
| 20% fat mealProvided to participants once throughout duration of study, contains 20% fat | Other | 20% fat meal |
| 40% fat mealProvided to participants once throughout duration of study, contains 40% fat | Other | 40% fat meal |
| 60% fat mealProvided to participants once throughout duration of study, contains 60% fat | Other | 60% fat meal |
| 80% fat mealProvided to participants once throughout duration of study, contains 80% fat | Other | 80% fat meal |
Primary outcome
Glucose tolerance
Time frame: Two hours (taking place following the 4-hour postprandial period)
A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption
6 secondary outcomes
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
Glucose and lipid metabolites
Time frame: During the 4-hour postprandial period
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 19 Aug 2025.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20% fat meal, 40% fat meal and 60% fat meal in people with Glucose Tolerance Impaired, run by McMaster University at 1 site in Canada.
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 8 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 19 Aug 2025. 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 Canada. 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?
Glucose tolerance (time frame: Two hours (taking place following the 4-hour postprandial period)). 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 19 Aug 2025.