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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061485
• Other study ID #: The FGF21-macro study
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: September 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sucrose
The participants consume A) water with 75 g sucrose
• Sucrose + protein
The participants consume B) water with 75 g sucrose + approx. 100 kcal protein
• Sucrose + fat
The participants C) water with 75 g sucrose + approx. 100 kcal fat

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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