Clinical trial NCT05061485: The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
Official title: The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
timeFrame: Difference in plasma concentration of FGF21 between two test days
Secondary outcomes:
measure: Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
timeFrame: Difference in plasma concentration of FGF21 between two test days
measure: Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in plasma concentration of glucose between the three test days
measure: Difference in insulin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in serum concentration of insulin between the three test days
measure: Difference in glucagon concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in plasma concentration of glucagon between the three test days
measure: Difference in triglyceride concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in serum concentration of triglycerides between the three test days
measure: Difference in amino acid concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in serum concentration of amino acids between the three test days
measure: Difference in glicentin concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in plasma glicentin between the three test days
measure: Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in plasma CCK between the three test days
measure: Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
timeFrame: Difference in appetite for sweet between the three test days
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
name: Matthew P Gillum
role: PRINCIPAL_INVESTIGATOR
References: