Effect of Matrices on Serum Fructose.

Effects of the Food Matrix on Serum Fructose Peaks

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.

Study Overview

• Status: Completed
• Conditions: Fructose Metabolism Disorder
• Intervention / Treatment: Other: Apple; Other: Mashed apple; Other: Apple juice; Other: Fructose powder in water

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Academic Hospital Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Food product 1.; [x] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.	Other: Apple; 20g fructose in [x] g of apple
Experimental: Food product 2.; [x] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.	Other: Mashed apple; 20g fructose in [x] g of mashed apple
Experimental: Food product 3.; [x] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time.	Other: Apple juice; 20g fructose in [x] ml 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; 20g fructose in [x] ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: NL81668.068.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No