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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Alessandro Leone
- Numer telefonu: 00390250316652
- E-mail: alessandro.leone1@unimi.it
Lokalizacje studiów
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Milan, Włochy, 20133
- Rekrutacyjny
- 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
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Kontakt:
- Alessandro Leone, Prof
- Numer telefonu: 00390250316652
- E-mail: alessandro.leone1@unimi.it
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Pod-śledczy:
- Alessandro Leone, Prof
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Główny śledczy:
- Simona Bertoli, Prof
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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Beverage containing medium-chain triglycerides (MCTs).
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Beverage containing long-chain triglycerides (LCTs).
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
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.
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
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Beta-hydroxybutyrate postprandial response
Ramy czasowe: Up to 300 minutes post-ingestion
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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
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Up to 300 minutes post-ingestion
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Glucose postprandial response
Ramy czasowe: Up to 300 minutes post-ingestion
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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.
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Up to 300 minutes post-ingestion
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Triglyceride postprandial response
Ramy czasowe: Up to 300 minutes post-ingestion
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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.
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Up to 300 minutes post-ingestion
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Fatty Acid Postprandial Response
Ramy czasowe: Up to 300 minutes post-ingestion
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Serum fatty acid concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
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Up to 300 minutes post-ingestion
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Ghrelin postprandial response
Ramy czasowe: Up to 300 minutes post-ingestion
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Blood ghrelin concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
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Up to 300 minutes post-ingestion
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Subjective appetite ratings (VAS)
Ramy czasowe: Up to 300 minutes post-ingestion
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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.
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Up to 300 minutes post-ingestion
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 101/25
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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