Effect of Matrices on Serum Fructose.

Study Overview
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Brief Summary
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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.

Official Title
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Effects of the Food Matrix on Serum Fructose Peaks

Conditions
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Fructose Metabolism Disorder

Intervention / Treatment
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* Other: Apple
* Other: Mashed apple
* Other: Apple juice
* Other: Fructose powder in water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food product 1.<br>[x] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. | Other: Apple<br>* 20g fructose in [x] g of apple<br>|
| Experimental: Food product 2.<br>[x] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. | Other: Mashed apple<br>* 20g fructose in [x] g of mashed apple<br>|
| Experimental: Food product 3.<br>[x] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time. | Other: Apple juice<br>* 20g fructose in [x] ml apple juice<br>|
| Experimental: Food product 4.<br>20 gr of fructose powder dissolved in 300 ml of water. Administered one time. | Other: Fructose powder in water<br>* 20g fructose in [x] ml water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |