Glucose Response, Ketone Body, Lipid Metabolism
Conditions
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.
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.
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.
Sponsors
University of Milan
University of Florence
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beta-hydroxybutyrate postprandial response | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatty Acid Postprandial Response | Up to 300 minutes post-ingestion | Serum fatty acid concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product. |
| Ghrelin postprandial response | Up to 300 minutes post-ingestion | Blood ghrelin concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product. |
| Subjective appetite ratings (VAS) | Up to 300 minutes post-ingestion | 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. |
Countries
Italy
Contacts
CONTACTAlessandro Leone
Outcome results
None listed