The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
30 mars 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Frederiksberg, Danmark, 1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Matthew P Gillum, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 september 2021
Primärt slutförande (Faktisk)
23 februari 2022
Avslutad studie (Faktisk)
23 februari 2022
Studieregistreringsdatum
Först inskickad
9 september 2021
Först inskickad som uppfyllde QC-kriterierna
27 september 2021
Första postat (Faktisk)
29 september 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2022
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- The FGF21-macro study
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