Effect of Matrices on Serum Fructose.

Not Applicable

Completed

• Conditions: Fructose Metabolism Disorder

• Registration Number: NCT05826717
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in serum fructose between peak and baseline	Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.	Millimeter of mercury
Serum uric acid	Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.	Millimoles per liter

Trial Locations

Locations (1)

Academic Hospital Maastricht; 🇳🇱 Maastricht, Netherlands