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

University of Copenhagen

Status: Completed

Conditions: Healthy

Treatments: Other: Sucrose + fat; Other: Sucrose; Other: Sucrose + protein

Study type: Interventional

Funder types: Other

Identifiers

NCT05061485

The FGF21-macro study

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Sucrose

Experimental group

Description:

The participants will be served a test drink with 75g sucrose dissolved in water

Treatment:

Other: Sucrose

Sucrose + protein

Experimental group

Description:

The participants will be served a test drink with 75g sucrose dissolved in water and \~ 100 kcal protein (whey protein)

Treatment:

Other: Sucrose + protein

Sucrose + fat

Experimental group

Description:

The participants will be served a test drink with 75g sucrose dissolved in water and \~ 100 kcal fat (cream)

Treatment:

Other: Sucrose + fat