To quantify fructose that escapes the portal circulation and appears in the systemic circulation, by measuring serum fructose using ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) within 150 minutes following intake of…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the fructose peak, defined as the maximal
incremental change from baseline.
Secondary outcome
Secondary study parameters include:
1. Systolic and diastolic blood pressure peak, defined as the maximal
incremental change from baseline.
2. Serum uric acid peak, defined as the maximal incremental change from
baseline.
Background summary
Epidemiological evidence is accumulating that a high consumption of added
sugars is associated with metabolic diseases such as type 2 diabetes. Fructose,
one of the principal added sugars, is believed to be the most disadvantageous
sugar. Data from a large population-based cohort demonstrated that fructose
intake from fruit juice and sugar-sweetened beverages, but not whole fruits, is
associated with higher intrahepatic lipid content. A study in mice demonstrated
that fast fructose exposure resulted in higher intrahepatic lipid content than
slow fructose exposure. The food matrix, i.e. the complex spatial organisation
of and interactions between nutrients, may account for the fast versus slow
fructose exposure and following health consequences. Therefore we aim to
investigate the role of the fructose matrices on serum fructose peaks. We
hypothesize that liquid fructose matrices will cause higher serum fructose
peaks in comparison to solid fructose matrices.
Study objective
To quantify fructose that escapes the portal circulation and appears in the
systemic circulation, by measuring serum fructose using ultraperformance liquid
chromatography-tandem mass spectrometry (UPLC-MS/MS) within 150 minutes
following intake of fructose-containing matrices.
Study design
This study is an open-label, randomized intervention study.
Intervention
Per visit, participants are provided a food product containing 20 g fructose.
This amount of fructose resembles a physiological intake of fructose.
The four fructose-containing food products include:
- Apple;
Jonagold apple, peeled and cored. A validated enzymatic assay (Enzytec* Generic
D-Glucose/D-Fructose/Sucrose #E1247, R-Biopharm® AG, Darmstadt Germany) is used
to measure fructose content of every individual apple used in the study. On
average, 230 g of Jonagold apple contains 20 g fructose.
- Shredded apple;
Jonagold apple, peeled and cored. A validated enzymatic assay (Enzytec* Generic
D-Glucose/D-Fructose/Sucrose #E1247, R-Biopharm® AG, Darmstadt Germany) is used
to measure fructose content of every individual apple used in the study. On
average, 230 g of Jonagold apple contains 20 g fructose. The apple will be
shredded using a blender. By shredding the apple, the food matrix, i.e. the
physical structure and spatial organisation of molecules, is disturbed.
- Apple juice;
Long shelf life, store bought apple juice (Goudappeltje 100% Puur sap,
Appelsientje®) contains juice from the concentrate of seven apples per litre
and is shortly heated to allow long storage. Fructose content per pack of apple
juice is measured with the enzymatic assay. Approximately 320 ml of apple juice
contains 20 g fructose.
- Fructose dissolved in water.
Fructose (C6H12O6; 1,3,4,5,6-pentahydroxyhexan-2-one); molecular weight
180.15588 g/moll) is a monosaccharide and produced as white crystals or powder,
with a sweet taste and no objectionable odours. In solution, fructose is
colourless, odourless, and clear to slightly turbid. It is widely used in the
food industry. Fructose is produced by NUTRICIA advanced medical nutrition for
oral administration
Study burden and risks
Considering the nature of the study, i.e. short-term and low protocol
complexity, low health risk, natural product use, small study population (N=18)
and healthy study population, the study is regarded as *low/negligible risk*.
Blood withdrawal could cause collapse, bleeding, hematoma, infection or nerve
damage. For this reason, blood withdrawal will be performed by experienced
staff.
P Debyelaan 25 25
Maastricht 6229HX
NL
P Debyelaan 25 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Body mass index (BMI) >=18.5 kg/m2 and <25 kg/m2
Exclusion criteria
- Pregnancy.
- Drugs and/or alcohol abuse.
- Diagnosis of diabetes mellitus.
- (History of) gastrointestinal and/or liver disease.
- (History of [< 5 years]) Ccancer (excluding basal cell carcinoma).
- Physical stress one month prior to inclusion (i.e. post-surgery, trauma that
requires medical treatment, or bacterial/viral/fungal infection or
extreme psychological stress).
Symptoms of infection include: fever, (excessive) sweating & chills, cough,
sore throat, shortness of breath, nasal congestion, diarrhea, vomiting, painful
miction, redness/swelling, stomach ache, head ache, and stiff neck.
- Unstable weight for 3 months prior to inclusion (i.e. 5% change in
bodyweight)(18).
- Allergy to one of the used food products in the study.
- Inability to provide written informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81668.068.22 |