Clinical trial NCT05826717: Effect of Matrices on Serum Fructose.
Official title: Effects of the Food Matrix on Serum Fructose Peaks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fructose Metabolism Disorder
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
Primary purpose: BASIC_SCIENCE

Brief summary: Epidemiological evidence is accumulating that a high consumption of added sugars is associated with metabolic diseases such as non-alcoholic fatty liver disease and 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 subsequent health consequences. Therefore the investigators aim to investigate the role of the fructose matrices on serum fructose peaks. The investigators hypothesize that liquid fructose matrices will cause higher serum fructose peaks in comparison to solid fructose matrices.

Objective: To quantify serum fructose peaks within 150 minutes following intake of fructose-containing matrices.


Eligibility criteria: 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 \[\< 5 years\] of) cancer (excluding basal cell carcinoma)
* Physical stress one month prior to inclusion (i.e. post-surgery, trauma that requires medical treatment, 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)
* Allergy to one of the used food products in the study.
* Inability to provide written informed consent.

Primary outcomes:
measure: Change in serum fructose between peak and baseline
timeFrame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
Secondary outcomes:
measure: Blood pressure
timeFrame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
measure: Serum uric acid
timeFrame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
Study officials:
References: