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

NCT05061485 | Completed

• 1 other identifier: The FGF21-macro study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat

  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 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 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 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 in serum concentration of triglycerides between the three test days

Study Arms (3)

Sucrose

EXPERIMENTAL

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

Other: Sucrose

Sucrose + protein

EXPERIMENTAL

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

Other: Sucrose + protein

Sucrose + fat

EXPERIMENTAL

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

Other: Sucrose + fat

Interventions

Sucrose OTHER

The participants consume A) water with 75 g sucrose

Sucrose

Sucrose + protein OTHER

The participants consume B) water with 75 g sucrose + approx. 100 kcal protein

Sucrose + protein

Sucrose + fat OTHER

The participants C) water with 75 g sucrose + approx. 100 kcal fat

Sucrose + fat

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent
• Caucasian
• Healthy men and women
• Age between 18-50 years
• Body mass index (BMI) between 20-27 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• Ramne S, Duizer L, Nielsen MS, Jorgensen NR, Svenningsen JS, Grarup N, Sjodin A, Raben A, Gillum MP. Meal sugar-protein balance determines postprandial FGF21 response in humans. Am J Physiol Endocrinol Metab. 2023 Nov 1;325(5):E491-E499. doi: 10.1152/ajpendo.00241.2023. Epub 2023 Sep 20.

  PMID: 37729024 DERIVED

MeSH Terms

Interventions

Sucrose; Proteins; CD36 Antigens

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Amino Acids, Peptides, and Proteins; Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• Matthew P Gillum

  Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 29, 2021
• Study Start: September 28, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-09

Locations

DK (1)