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Effect of Matrices on Serum Fructose.

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Fructose Metabolism Disorder

Treatments

Other: Apple
Other: Apple juice
Other: Mashed apple
Other: Fructose powder in water

Study type

Interventional

Funder types

Other

Identifiers

NCT05826717
NL81668.068.22

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

23 participants in 4 patient groups

Food product 1.
Experimental group
Description:
\[x\] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Treatment:
Other: Apple
Food product 2.
Experimental group
Description:
\[x\] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Food product 3.
Experimental group
Description:
\[x\] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Treatment:
Other: Apple juice
Food product 4.
Experimental group
Description:
20 gr of fructose powder dissolved in 300 ml of water. Administered one time.
Treatment:
Other: Fructose powder in water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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