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The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion

30 maart 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Denemarken
      • Frederiksberg, Denemarken, 1958
        • Department of Nutrition, Exercise and sports, University of Copenhagen

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Sucrose
The participants will be served a test drink with 75g sucrose dissolved in water
Ander: Sucrose
The participants consume A) water with 75 g sucrose
Experimenteel: Sucrose + protein
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein)
Ander: Sucrose + protein
The participants consume B) water with 75 g sucrose + approx. 100 kcal protein
Experimenteel: Sucrose + fat
The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream)
Ander: Sucrose + fat
The participants C) water with 75 g sucrose + approx. 100 kcal fat

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Tijdsspanne: Difference in plasma concentration of FGF21 between two test days
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.
Difference in plasma concentration of FGF21 between two test days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Tijdsspanne: Difference in plasma concentration of FGF21 between two test days
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.
Difference in plasma concentration of FGF21 between two test days
Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in plasma concentration of glucose between the three test days
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.
Difference in plasma concentration of glucose between the three test days
Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in serum concentration of insulin between the three test days
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.
Difference in serum concentration of insulin between the three test days
Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in plasma concentration of glucagon between the three test days
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.
Difference in plasma concentration of glucagon between the three test days
Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in serum concentration of triglycerides between the three test days
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.
Difference in serum concentration of triglycerides between the three test days
Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in serum concentration of amino acids between the three test days
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.
Difference in serum concentration of amino acids between the three test days
Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in plasma glicentin between the three test days
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.
Difference in plasma glicentin between the three test days
Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in plasma CCK between the three test days
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.
Difference in plasma CCK between the three test days
Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Tijdsspanne: Difference in appetite for sweet between the three test days
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.
Difference in appetite for sweet between the three test days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Copenhagen

Onderzoekers

  • Hoofdonderzoeker: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 september 2021

Primaire voltooiing (Werkelijk)

23 februari 2022

Studie voltooiing (Werkelijk)

23 februari 2022

Studieregistratiedata

Eerst ingediend

9 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

27 september 2021

Eerst geplaatst (Werkelijk)

29 september 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

30 maart 2022

Laatst geverifieerd

1 september 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • The FGF21-macro study

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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