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RecruitingNCT07718048Updated Jul 21, 2026

Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults

An interventional study of MCT Beverage and LCT Beverage in Ketone Body, Lipid Metabolism and Glucose Response, sponsored by University of Milan. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by University of Milan · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Ketone Body
  • Lipid Metabolism
  • Glucose Response
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult participants
  • Age between 18 and 40 years
  • Ability to understand the study procedures and provide informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    All Interventions (Crossover)

    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.

    Other: MCT Beverage · Other: LCT Beverage · Other: Synthetic MCT Powder · Other: Natural MCT Powder · Other: MCT Biscuit

Interventions

  • OtherMCT Beverage

    Beverage containing medium-chain triglycerides (MCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.

  • OtherLCT Beverage

    Beverage containing long-chain triglycerides (LCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.

  • OtherSynthetic MCT Powder

    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.

  • OtherNatural MCT Powder

    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

  • OtherMCT Biscuit

    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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 300 minutes post-ingestion

  2. 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.

    Time frame: Up to 300 minutes post-ingestion

  3. 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.

    Time frame: Up to 300 minutes post-ingestion

Secondary outcomes

  1. 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.

    Time frame: Up to 300 minutes post-ingestion

  2. 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.

    Time frame: Up to 300 minutes post-ingestion

  3. Subjective appetite ratings (VAS)

    Subjective appetite assessed using visual analogue scales (VAS) at baseline, immediately after product consumption, and at 30, 60, 90, 120, 180, 240, and 300 minutes post-ingestion.

    Time frame: Up to 300 minutes post-ingestion

06

Study locations

1 of 1 sites 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, Italy
    • Alessandro Leone, Prof · Contact · alessandro.leone1@unimi.it · 00390250316652
    • Alessandro Leone, Prof · Sub investigator
    • Simona Bertoli, Prof · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07718048
Lead sponsor
University of Milan
Collaborators
University of Florence
Responsible party
Simona Bertoli (Prof., University of Milan) — Principal investigator
First posted
Jul 21, 2026
Start date
Jan 13, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 21, 2026

Study contacts

Alessandro Leone
Contact
alessandro.leone1@unimi.it
00390250316652

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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