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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Sucrose; Other: Sucrose + protein; Other: Sucrose + fat

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sucrose; The participants will be served a test drink with 75g sucrose dissolved in water	Other: Sucrose; The participants consume A) water with 75 g sucrose
Experimental: Sucrose + protein; The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein)	Other: Sucrose + protein; The participants consume B) water with 75 g sucrose + approx. 100 kcal protein
Experimental: Sucrose + fat; The participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream)	Other: Sucrose + fat; The participants C) water with 75 g sucrose + approx. 100 kcal fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat	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.	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.	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.	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.	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.	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.	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.	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.	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: The FGF21-macro study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No