HealthyNCT05061485
The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
A study testing Sucrose, Sucrose + protein and Sucrose + fat in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sucrose, Sucrose + protein and Sucrose + fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Sep 2021to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- Caucasian
- Healthy men and women
- Age between 18-50 years
- Body mass index (BMI) between 20-27 kg/m2
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, 1958
About this study
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
- Being tested
- Sucrose, Sucrose + protein, Sucrose + fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseOther
The participants consume A) water with 75 g sucrose
Sucrose + proteinOther
The participants consume B) water with 75 g sucrose + approx. 100 kcal protein
Sucrose + fatOther
The participants C) water with 75 g sucrose + approx. 100 kcal fat
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | The participants will be served a test drink with 75g sucrose dissolved in water Receives: 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) Receives: 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) Receives: Other: Sucrose + fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Difference in appetite for sweet between the three test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start28 Sep 2021
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew P Gillum, Principal investigator, Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061485
- Sponsor's protocol ID
- The FGF21-macro study
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37729024
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Macronutrients on Fibroblast Growth Factor 21 (FGF21) Secretion
- ClinicalTrials.gov ID
- NCT05061485
- Acronym / sponsor ID
- The FGF21-macro study
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Other: SucroseThe participants will be served a test drink with 75g sucrose dissolved in water |
| Sucrose + protein | Experimental | Other: Sucrose + proteinThe participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal protein (whey protein) |
| Sucrose + fat | Experimental | Other: Sucrose + fatThe participants will be served a test drink with 75g sucrose dissolved in water and ~ 100 kcal fat (cream) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent
- Caucasian
- Healthy men and women
- Age between 18-50 years
- Body mass index (BMI) between 20-27 kg/m2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucroseThe participants consume A) water with 75 g sucrose | Other | Sucrose |
| Sucrose + proteinThe participants consume B) water with 75 g sucrose + approx. 100 kcal protein | Other | Sucrose + protein |
| Sucrose + fatThe participants C) water with 75 g sucrose + approx. 100 kcal fat | Other | Sucrose + fat |
Primary outcome
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein
Time frame: Difference in plasma concentration of FGF21 between two test days
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.
9 secondary outcomes
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+fat
Time frame: Difference in plasma concentration of FGF21 between two test days
Difference in glucose concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Difference in plasma glicentin between the three test days
Difference in CCK concentration after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Time frame: Difference in plasma CCK between the three test days
Difference in appetite for sweet after consumption of sucrose vs. sucrose+protein vs. sucrose+fat.
Time frame: Difference in appetite for sweet between the three test days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37729024Ramne 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew P Gillum principal investigator
Novo Nordisk Foundation Center for Basic Metabolic Research, Health and Medical Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose, Sucrose + protein and Sucrose + fat in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in FGF21 concentration after consumption of sucrose vs. sucrose+protein (time frame: Difference in plasma concentration of FGF21 between two test days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.