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Completed

NCT Number: NCT05826717

Effect of Matrices on Serum Fructose.

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.

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Key information

Conditions

Fructose Metabolism Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Hospital Maastricht

Maastricht, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apple

Other

20g fructose in [x] g of apple

Mashed apple

Other

20g fructose in [x] g of mashed apple

Apple juice

Other

20g fructose in [x] ml apple juice

Fructose powder in water

Other

20g fructose in [x] ml water

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

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

    Millimeter of mercury

  2. Serum uric acid

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

    Millimoles per liter

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Effects of the Food Matrix on Serum Fructose Peaks

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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