Effect of Matrices on Serum Fructose.

Fructose Metabolism Disorder Clinical Trial

Official title:

Effects of the Food Matrix on Serum Fructose Peaks

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05826717
• Other study ID #: NL81668.068.22
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fructose Metabolism Disorder
• Metabolic Diseases

Intervention

Other:
• Apple
20g fructose in [x] g of apple
• Mashed apple
20g fructose in [x] g of mashed apple
• Apple juice
20g fructose in [x] ml apple juice
• Fructose powder in water
20g fructose in [x] ml water

Locations

Country	Name	City	State
Netherlands	Academic Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.