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

NCT ID: NCT05061485

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2022-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sucrose

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

Group Type EXPERIMENTAL

Sucrose

Intervention Type OTHER

The participants consume A) water with 75 g sucrose

Sucrose + protein

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

Group Type EXPERIMENTAL

Sucrose + protein

Intervention Type OTHER

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

Sucrose + fat

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

Group Type EXPERIMENTAL

Sucrose + fat

Intervention Type OTHER

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

Interventions

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Sucrose

The participants consume A) water with 75 g sucrose

Intervention Type OTHER

Sucrose + protein

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

Intervention Type OTHER

Sucrose + fat

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew P Gillum

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 37729024 (View on PubMed)

Other Identifiers

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The FGF21-macro study

Identifier Type: -

Identifier Source: org_study_id

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