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CompletedNCT05826717Updated Feb 20, 2025

Effect of Matrices on Serum Fructose.

An interventional study of Apple and Mashed apple in Fructose Metabolism Disorder, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fructose Metabolism Disorder

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03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 23 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥ 18 years.
  • Body mass index (BMI) ≥18.5 kg/m2 and \<25 kg/m2

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Food product 1.

    \[x\] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.

    Other: Apple

  • Experimental
    Food product 2.

    \[x\] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.

  • Experimental
    Food product 3.

    \[x\] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time.

    Other: Apple juice

  • Experimental
    Food product 4.

    20 gr of fructose powder dissolved in 300 ml of water. Administered one time.

    Other: Fructose powder in water

Interventions

  • OtherApple

    20g fructose in \[x\] g of apple

  • OtherMashed apple

    20g fructose in \[x\] g of mashed apple

  • OtherApple juice

    20g fructose in \[x\] ml apple juice

  • OtherFructose powder in water

    20g fructose in \[x\] ml water

06

What researchers measure

Primary outcomes

  1. Change in serum fructose between peak and baseline

    Time frame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.

Secondary outcomes

  1. Blood pressure

    Millimeter of mercury

    Time frame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.

  2. Serum uric acid

    Millimoles per liter

    Time frame: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.

07

Study locations

1 site
  • Academic Hospital Maastricht
    Maastricht, 6229 HX, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05826717
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Apr 24, 2023
Start date
Dec 15, 2022
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Feb 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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