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

NCT07718048 | Recruiting

• 1 other identifier: 101/25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ketone Body; Lipid Metabolism; Glucose Response

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Fatty Acid Postprandial Response

  Up to 300 minutes post-ingestion

• Ghrelin postprandial response

  Up to 300 minutes post-ingestion

• Subjective appetite ratings (VAS)

  Up to 300 minutes post-ingestion

Study Arms (1)

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.

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

Interventions

MCT Beverage OTHER

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

All Interventions (Crossover)

LCT Beverage OTHER

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

All Interventions (Crossover)

Synthetic MCT Powder OTHER

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.

All Interventions (Crossover)

Natural MCT Powder OTHER

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

All Interventions (Crossover)

MCT Biscuit OTHER

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.

All Interventions (Crossover)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• University of Florence: collaborator

Study Sites (1)

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

RECRUITING

Central Study Contacts

Alessandro Leone

CONTACT

00390250316652; alessandro.leone1@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)