The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
30 marca 2022 zaktualizowane przez: University of Copenhagen
The aim of this randomized cross-over study is to investigate how consumption of protein and fat affects the FGF21 response triggered by sucrose. The hypothesis is that the consumption of protein, but not fat, will attenuate the FGF21 response triggered by sucrose.
Exploratory, and in order to investigate mechanisms behind the potential attenuation in the sucrose-induced FGF21 response after protein consumption, glucose, insulin, glucagon, triglycerides, amino acids, glicentin and cholecystokinin (CCK) will be assessed before and after consumption of sucrose, sucrose+protein and sucrose+fat. Furthermore, the association between the FGF21 response after consumption of sucrose, sucrose + protein and sucrose + fat and subjective rating of appetite for sweet will also be investigated.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Frederiksberg, Dania, 1958
- Department of Nutrition, Exercise and Sports, University of Copenhagen
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 50 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Informed consent
- Caucasian
- Healthy men and women
- Age between 18-50 years
- Body mass index (BMI) between 20-27 kg/m2
Exclusion Criteria:
- Chronic diseases or significant health problems that are disruptive for participation in the study (as judged by the principal investigator/clinical responsible)
- Use, currently or within the previous 3 months, of medication that has the potential of affecting any of the blood parameters assessed in the study (as judged by the principal investigator/clinical responsible)
- Blood donation within the last 3 months or during the study period
- Smoking, smoking cessation within the past 3 months, or nicotine use (electronic cigarettes, gum, etc.)
- Currently dieting or having lost/gained a significant amount of weight (±3 kg) in the previous 3 months
- Women who are pregnant, breast-feeding or have the intention of becoming pregnant during the study period
- Food allergies or food intolerance relevant for the study
- Substance abuse (within the last 12 months)
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- Simultaneous participation in other clinical studies that can interfere with the current study
- Inability, physically or mentally, to comply with the procedures required by the study protocol
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Sucrose
The participants will be served a test drink with 75g sucrose dissolved in water
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The participants consume A) water with 75 g sucrose
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Eksperymentalny: Sucrose + protein
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein)
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The participants consume B) water with 75 g sucrose + approx.
100 kcal protein
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Eksperymentalny: Sucrose + fat
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream)
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The participants C) water with 75 g sucrose + approx.
100 kcal fat
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Ramy czasowe: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+protein.
Concentration of FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Ramy czasowe: Difference in plasma concentration of FGF21 between two test days
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Difference (pg/ml) in plasma FGF21 concentration after consumption of sucrose vs. sucrose+fat.
FGF21 is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of FGF21 between two test days
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Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in plasma concentration of glucose between the three test days
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Difference (mmol/l) in plasma glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucose is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucose between the three test days
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Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in serum concentration of insulin between the three test days
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Difference (pmol/l) in serum insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Insulin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of insulin between the three test days
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Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in plasma concentration of glucagon between the three test days
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Difference (pg/ml) in plasma glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glucagon is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma concentration of glucagon between the three test days
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Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in serum concentration of triglycerides between the three test days
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Difference (mmol/l) in serum triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Triglyceride is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of triglycerides between the three test days
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Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in serum concentration of amino acids between the three test days
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Difference in serum amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Amino acids are measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in serum concentration of amino acids between the three test days
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Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in plasma glicentin between the three test days
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Difference (pmol/l) in plasma glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Glicentin is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma glicentin between the three test days
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Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in plasma CCK between the three test days
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Difference (pmol/l) in plasma CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
CCK is measured at time 0 and 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in plasma CCK between the three test days
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Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Ramy czasowe: Difference in appetite for sweet between the three test days
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Difference in appetite for sweet is measured using visual analog scales (VAS).
The VAS consists of a 100 mm horizontal unbroken line with words anchored at each end describing the extremes.
The participants respond to the question asked by placing a vertical mark through the horizontal line corresponding to their perceived feeling at that particular time.
Appetite for sweet is assessed at time 0 and 30, 60, 120, 180, and 240 min after consuming the test drinks.
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Difference in appetite for sweet between the three test days
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
28 września 2021
Zakończenie podstawowe (Rzeczywisty)
23 lutego 2022
Ukończenie studiów (Rzeczywisty)
23 lutego 2022
Daty rejestracji na studia
Pierwszy przesłany
9 września 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 września 2021
Pierwszy wysłany (Rzeczywisty)
29 września 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
31 marca 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 marca 2022
Ostatnia weryfikacja
1 września 2021
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- The FGF21-macro study
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .