Test MealFruPPNCT03195062
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)
A study testing Test meal in people with Test Meal, run by University of Lausanne at 1 site in Switzerland.
Trial summary
In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Test Meal
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Mar 2017to 31 Aug 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged from 18 to 40 years
- Body Mass Index of 18.5 to 25 kg/m²
- Sex male of female
Who cannot join
- Fructose intolerance
- Antidiabetic and hypolipemic drugs
- Alcohol consumption >10g/day
- Severe eating disorders
- Severe psychological problems
- Vegetarian diet or other specific diet
Show all 9Show fewer
- Consumption of illicit substances
- Pregnancy
- Weight gain or weight loss > 3 kg in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.
The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.
- Conditions
- Test Meal
- Being tested
- Test meal
- Keywords
- Fructose, Obesity, Metabolism, Post-prandial kinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealOther
Liquid test meal (fructose+glucose)
| Study group | Role | What they receive |
|---|---|---|
| Test meal | Experimental | The subjects will receive a liquid test meal containing glucose and fructose with 13C fructose. Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion.
Calculation with 13C fructose enrichment in blood samples at T0; 30; 60; 90; 120; 150; 180; 210 and 240 min.
Measured: The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start23 Mar 2017
- Primary completion30 Jun 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test MealStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195062
- Sponsor's protocol ID
- 2016-01828
- Other IDs
- 2016
- Acronym
- FruPP
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2017
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)
- ClinicalTrials.gov ID
- NCT03195062
- Acronym / sponsor ID
- FruPP / 2016-01828
- Conditions
- Test Meal
- Keywords
- Fructose, Obesity, Metabolism, Post-prandial kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Jun 2017 (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.
In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.
The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test meal | Experimental | Other: Test mealThe subjects will receive a liquid test meal containing glucose and fructose with 13C fructose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged from 18 to 40 years
- Body Mass Index of 18.5 to 25 kg/m²
- Sex male of female
Key exclusion criteria (9 listed)
- Fructose intolerance
- Antidiabetic and hypolipemic drugs
- Alcohol consumption >10g/day
- Severe eating disorders
- Severe psychological problems
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 |
|---|---|---|
| Test mealLiquid test meal (fructose+glucose) | Other | Test meal |
Primary outcome
Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion.
Time frame: The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.
Calculation with 13C fructose enrichment in blood samples at T0; 30; 60; 90; 120; 150; 180; 210 and 240 min.
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 18 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Test Meal, run by University of Lausanne at 1 site in Switzerland.
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 3 inclusion and 9 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 18 Oct 2018. 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 Switzerland. 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?
Measurement of the amount of fructose that escape first-pass hepatic extraction after oral ingestion. (time frame: The quantity of 13C fructose will be calculated, during the post prandial period, until 240 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018.