Ketone BodyNCT07718048
Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults
A study testing MCT Beverage, LCT Beverage and Synthetic MCT Powder in people with Ketone Body and Lipid Metabolism, run by University of Milan at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the effects of medium-chain triglycerides (MCTs), delivered in different formulations, on beta-hydroxybutyrate response (as a marker of ketone body production), lipid metabolism, and glucose responses in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketone Body, Lipid Metabolism, Glucose Response
- What is being tested?
- MCT Beverage, LCT Beverage and Synthetic MCT Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy adult participants
- Age between 18 and 40 years
- Ability to understand the study procedures and provide informed consent
Who cannot join
- Alterations in glucose or lipid metabolism
- Diseases requiring the use of medications that affect glucose or lipid metabolism
- Reported or diagnosed malabsorption conditions
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
International Center for the Assessment of Nutritional Status and the development of Dietary Intervention Strategies (ICANS-DIS), Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan
Milan, 20133
Alessandro Leone, Prof, 00390250316652, alessandro.leone1@unimi.it
Alessandro Leone, Prof
About this study
Official title: Acute Effects of Different Medium-Chain Triglyceride (MCT) Formulations on Ketone Body Production, Plasma Lipid Profile, and Glucose Levels in Healthy Adults: a Randomized Crossover Study
The goal of this clinical trial is to evaluate the effects of medium-chain triglycerides (MCTs), delivered in different formulations, on beta-hydroxybutyrate response (as a marker of ketone body production), lipid metabolism, and glucose responses in healthy adults.
The main questions it aims to answer are:
Read more
Do MCTs influence beta-hydroxybutyrate responses, lipid metabolism, and glucose responses differently compared to long-chain triglycerides (LCTs)?
Do different types of MCTs (natural sources containing C8 to C12 versus synthetic formulations containing only C8 and C10) lead to different beta-hydroxybutyrate, lipid, and glucose responses?
Does the form in which MCTs are consumed (e.g., powders or incorporated into foods) influence beta-hydroxybutyrate production, lipid metabolism, and glucose responses?
Researchers will compare five different lipid formulations to evaluate their effects on postprandial beta-hydroxybutyrate concentrations, blood lipid levels, and glucose.
Participants will:
Consume five different test products on separate study visits. Provide blood samples for up to five hours after each intake for metabolic measurements.
Read the detailed description
This randomized crossover study is designed to evaluate the metabolic effects of five different lipid-based formulations in healthy adults. Medium-chain triglycerides (MCTs) are known to be rapidly absorbed and metabolized, promoting the production of ketone bodies, which can serve as an alternative energy source. However, metabolic responses to MCTs may vary depending on their fatty acid composition and the form in which they are consumed.
The study compares different lipid formulations, including long-chain triglycerides (LCTs), synthetic MCTs composed of C8 and C10 fatty acids, and MCTs derived from natural sources such as coconut oil (containing C8 to C12 fatty acids). In addition, the study evaluates the impact of the food matrix by comparing similar lipid compositions provided in different forms, including reconstituted powders and a solid food product.
Participants attend multiple study visits after an overnight fast and consume each test product in a randomized order. The amount of each product is adjusted to provide a standardized lipid dose of 0.5 g/kg of body weight, and a washout period of at least 7 days is applied between visits.
During each visit, blood samples are collected over a period of up to 5 hours after product consumption. Primary metabolic outcomes include postprandial beta-hydroxybutyrate concentrations (as a marker of ketone body production), glucose response, and triglyceride response. Secondary outcomes include circulating fatty acid profiles, ghrelin concentrations, and subjective appetite ratings assessed using visual analogue scales.
- Conditions
- Ketone Body, Lipid Metabolism, Glucose Response
- Being tested
- MCT Beverage, LCT Beverage, Synthetic MCT Powder, Natural MCT Powder, MCT Biscuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT BeverageOther
Beverage containing medium-chain triglycerides (MCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
LCT BeverageOther
Beverage containing long-chain triglycerides (LCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Synthetic MCT PowderOther
Powder formulation containing synthetic medium-chain triglycerides (MCTs) composed of C8 and C10 fatty acids, reconstituted in water before consumption. Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Natural MCT PowderOther
Powder formulation containing medium-chain triglycerides (MCTs) derived from coconut oil (containing fatty acids from C8 to C12), reconstituted in water before consumption. Administered to provide a lipid dose of 0.5 g/kg of body weight
MCT BiscuitOther
Biscuit containing medium-chain triglycerides (MCTs) derived from coconut oil. Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| All Interventions (Crossover) | Experimental | Participants receive all five test products in a randomized crossover design. The order of administration is randomized, and each product is provided in an amount adjusted to deliver a standardized lipid dose of 0.5 g/kg of body weight. A washout period of at least 7 days is applied between interventions. Receives: Other: MCT Beverage; Other: LCT Beverage; Other: Synthetic MCT Powder; Other: Natural MCT Powder; Other: MCT Biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-hydroxybutyrate postprandial response
Beta-hydroxybutyrate concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time
Measured: Up to 300 minutes post-ingestion
Glucose postprandial response
Serum glucose concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
Measured: Up to 300 minutes post-ingestion
Triglyceride postprandial response
Serum triglyceride concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
Measured: Up to 300 minutes post-ingestion
Secondary outcomes (3)
Fatty Acid Postprandial Response
Serum fatty acid concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
Measured: Up to 300 minutes post-ingestion
Ghrelin postprandial response
Blood ghrelin concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
Measured: Up to 300 minutes post-ingestion
Subjective appetite ratings (VAS)
Subjective appetite assessed using a 100-mm Visual Analogue Scale (VAS), anchored at either end with opposite statements ("not at all" and "very much"), at baseline, immediately after product consumption, and at 30, 60, 90, 120, 180, 240, and 300 minutes post-ingestion. Scores range from 0 to 100 mm, with higher scores indicating a greater intensity of the assessed sensation.
Measured: Up to 300 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start13 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketone BodyStudies 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
- Crossover
- Model description
- Participants are enrolled in a randomized crossover study in which each subject receives all five test products in a random sequence. Each intervention consists of a different test product designed to compare lipid formulations varying in fatty acid composition, nature of fatty acids and food matrix. Products include: a beverage with medium-chain triglycerides (MCTs), a beverage with long-chain triglycerides (LCTs), a powder of synthetic MCTs (C8 and C10), a powder of natural MCTs (C8-C12), and a biscuit containing natural MCTs. The amount of product is adjusted to provide a standardized lipid dose of 0.5 g/kg body weight. Participants attend each visit after ≥12 hours fasting. Blood samples are collected at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after product consumption. A washout of at least 7 days is applied between visits.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Principal investigator, Simona Bertoli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718048
- Sponsor's protocol ID
- 101/25
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Different Medium-Chain Triglyceride (MCT) Formulations on Ketone Body Production, Plasma Lipid Profile, and Glucose Levels in Healthy Adults: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07718048
- Acronym / sponsor ID
- 101/25
- Conditions
- Ketone Body, Lipid Metabolism, Glucose Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Jul 2026 (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 evaluate the effects of medium-chain triglycerides (MCTs), delivered in different formulations, on beta-hydroxybutyrate response (as a marker of ketone body production), lipid metabolism, and glucose responses in healthy adults.
The main questions it aims to answer are:
Do MCTs influence beta-hydroxybutyrate responses, lipid metabolism, and glucose responses differently compared to long-chain triglycerides (LCTs)?
Do different types of MCTs (natural sources containing C8 to C12 versus synthetic formulations containing only C8 and C10) lead to different beta-hydroxybutyrate, lipid, and glucose responses?
Does the form in which MCTs are consumed (e.g., powders or incorporated into foods) influence beta-hydroxybutyrate production, lipid metabolism, and glucose responses?
Researchers will compare five different lipid formulations to evaluate their effects on postprandial beta-hydroxybutyrate concentrations, blood lipid levels, and glucose.
Participants will:
Consume five different test products on separate study visits. Provide blood samples for up to five hours after each intake for metabolic measurements.
Detailed description
This randomized crossover study is designed to evaluate the metabolic effects of five different lipid-based formulations in healthy adults. Medium-chain triglycerides (MCTs) are known to be rapidly absorbed and metabolized, promoting the production of ketone bodies, which can serve as an alternative energy source. However, metabolic responses to MCTs may vary depending on their fatty acid composition and the form in which they are consumed.
The study compares different lipid formulations, including long-chain triglycerides (LCTs), synthetic MCTs composed of C8 and C10 fatty acids, and MCTs derived from natural sources such as coconut oil (containing C8 to C12 fatty acids). In addition, the study evaluates the impact of the food matrix by comparing similar lipid compositions provided in different forms, including reconstituted powders and a solid food product.
Participants attend multiple study visits after an overnight fast and consume each test product in a randomized order. The amount of each product is adjusted to provide a standardized lipid dose of 0.5 g/kg of body weight, and a washout period of at least 7 days is applied between visits.
During each visit, blood samples are collected over a period of up to 5 hours after product consumption. Primary metabolic outcomes include postprandial beta-hydroxybutyrate concentrations (as a marker of ketone body production), glucose response, and triglyceride response. Secondary outcomes include circulating fatty acid profiles, ghrelin concentrations, and subjective appetite ratings assessed using visual analogue scales.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are enrolled in a randomized crossover study in which each subject receives all five test products in a random sequence. Each intervention consists of a different test product designed to compare lipid formulations varying in fatty acid composition, nature of fatty acids and food matrix. Products include: a beverage with medium-chain triglycerides (MCTs), a beverage with long-chain triglycerides (LCTs), a powder of synthetic MCTs (C8 and C10), a powder of natural MCTs (C8-C12), and a biscuit containing natural MCTs. The amount of product is adjusted to provide a standardized lipid dose of 0.5 g/kg body weight. Participants attend each visit after ≥12 hours fasting. Blood samples are collected at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after product consumption. A washout of at least 7 days is applied between visits.
| Arm | Type | Receives |
|---|---|---|
| All Interventions (Crossover) | Experimental | Other: MCT Beverage, Other: LCT Beverage, Other: Synthetic MCT Powder, Other: Natural MCT Powder, Other: MCT BiscuitParticipants receive all five test products in a randomized crossover design. The order of administration is randomized, and each product is provided in an amount adjusted to deliver a standardized lipid dose of 0.5 g/kg of body weight. A washout period of at least 7 days is applied between interventions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult participants
- Age between 18 and 40 years
- Ability to understand the study procedures and provide informed consent
Key exclusion criteria (4 listed)
- Alterations in glucose or lipid metabolism
- Diseases requiring the use of medications that affect glucose or lipid metabolism
- Reported or diagnosed malabsorption conditions
- Pregnancy or breastfeeding
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 |
|---|---|---|
| MCT BeverageBeverage containing medium-chain triglycerides (MCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight. | Other | All Interventions (Crossover) |
| LCT BeverageBeverage containing long-chain triglycerides (LCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight. | Other | All Interventions (Crossover) |
| Synthetic MCT PowderPowder formulation containing synthetic medium-chain triglycerides (MCTs) composed of C8 and C10 fatty acids, reconstituted in water before consumption. Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight. | Other | All Interventions (Crossover) |
| Natural MCT PowderPowder formulation containing medium-chain triglycerides (MCTs) derived from coconut oil (containing fatty acids from C8 to C12), reconstituted in water before consumption. Administered to provide a lipid dose of 0.5 g/kg of body weight | Other | All Interventions (Crossover) |
| MCT BiscuitBiscuit containing medium-chain triglycerides (MCTs) derived from coconut oil. Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight. | Other | All Interventions (Crossover) |
Primary outcome
Beta-hydroxybutyrate postprandial response
Time frame: Up to 300 minutes post-ingestion
Beta-hydroxybutyrate concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time
Glucose postprandial response
Time frame: Up to 300 minutes post-ingestion
Serum glucose concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
Triglyceride postprandial response
Time frame: Up to 300 minutes post-ingestion
Serum triglyceride concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
3 secondary outcomes
Fatty Acid Postprandial Response
Time frame: Up to 300 minutes post-ingestion
Ghrelin postprandial response
Time frame: Up to 300 minutes post-ingestion
Subjective appetite ratings (VAS)
Time frame: Up to 300 minutes post-ingestion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCT Beverage, LCT Beverage and Synthetic MCT Powder in people with Ketone Body and Lipid Metabolism, run by University of Milan at 1 site in Italy.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Sep 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Leone (00390250316652, alessandro.leone1@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-hydroxybutyrate postprandial response (time frame: Up to 300 minutes post-ingestion). The study lists 3 primary outcomes in all. 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 30 Sep 2026.