Effect of Matrices on Serum Fructose.

NCT05826717 | Completed

• 1 other identifier: NL81668.068.22
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Fructose Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood pressure

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

• Serum uric acid

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

Study Arms (4)

Food product 1.

EXPERIMENTAL

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

Other: Apple

Food product 2.

EXPERIMENTAL

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

Food product 3.

EXPERIMENTAL

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

Other: Apple juice

Food product 4.

EXPERIMENTAL

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

Other: Fructose powder in water

Interventions

Apple OTHER

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

Food product 1.

Mashed apple OTHER

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

Apple juice OTHER

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

Food product 3.

Fructose powder in water OTHER

20g fructose in \[x\] ml water

Food product 4.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Allergy to one of the used food products in the study.
• Inability to provide written informed consent.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Academic Hospital Maastricht

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an open-label, randomized, single meal, cross-over study in healthy individuals.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: December 15, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

NL (1)