The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
30. März 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Frederiksberg, Dänemark, 1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
28. September 2021
Primärer Abschluss (Tatsächlich)
23. Februar 2022
Studienabschluss (Tatsächlich)
23. Februar 2022
Studienanmeldedaten
Zuerst eingereicht
9. September 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. September 2021
Zuerst gepostet (Tatsächlich)
29. September 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
31. März 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. März 2022
Zuletzt verifiziert
1. September 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- The FGF21-macro study
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