Effect of Matrices on Serum Fructose.

NCT ID: NCT05826717

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Fructose Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Food product 1.

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

Group Type EXPERIMENTAL

Apple

Intervention Type OTHER

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

Food product 2.

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

Group Type EXPERIMENTAL

No interventions assigned to this group

Food product 3.

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

Group Type EXPERIMENTAL

Apple juice

Intervention Type OTHER

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

Food product 4.

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

Group Type EXPERIMENTAL

Fructose powder in water

Intervention Type OTHER

20g fructose in \[x\] ml water

Interventions

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Apple

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

Intervention Type OTHER

Mashed apple

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

Intervention Type OTHER

Apple juice

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

Intervention Type OTHER

Fructose powder in water

20g fructose in \[x\] ml water

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academic Hospital Maastricht

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL81668.068.22

Identifier Type: -

Identifier Source: org_study_id

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