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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Lipid Metabolism; Glucose Response; Ketone Body
• Intervention / Treatment: Other: MCT Beverage; Other: LCT Beverage; Other: Synthetic MCT Powder; Other: Natural MCT Powder; Other: MCT Biscuit

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Leone; Phone Number: 00390250316652; Email: alessandro.leone1@unimi.it

Study Locations

• Italy
  • Milan, Italy, 20133
    • 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
    • Contact: Alessandro Leone, Prof; Phone Number: 00390250316652; Email: alessandro.leone1@unimi.it
    • Sub-Investigator: Alessandro Leone, Prof
    • Principal Investigator: Simona Bertoli, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; Beverage containing medium-chain triglycerides (MCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.; Other: LCT 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.; Other: Synthetic 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.; Other: Natural 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; Other: MCT 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Up to 300 minutes post-ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 300 minutes post-ingestion
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.	Up to 300 minutes post-ingestion

Collaborators and Investigators

• Sponsor: University of Milan
• Collaborators: University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 101/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No