Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Milan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult participants
Age between 18 and 40 years
Ability to understand the study procedures and provide informed consent
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
MCT Beverage
Other interventionBeverage containing medium-chain triglycerides (MCTs). Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
LCT Beverage
Other interventionBeverage 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 Powder
Other interventionPowder 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 Powder
Other interventionPowder 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 Biscuit
Other interventionBiscuit 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: All Interventions (Crossover)Experimental treatment 5 interventions
Trial outcomes
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-ingestion2
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-ingestion3
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-ingestionSecondary 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-ingestion2
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-ingestion3
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.
Time frame
Up to 300 minutes post-ingestionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Milan
Lead sponsor
University of Florence
Collaborator
Source ClinicalTrials.gov