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Effect of Matrices on Serum Fructose.

Primary Purpose

Fructose Metabolism Disorder

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Apple
Mashed apple
Apple juice
Fructose powder in water
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fructose Metabolism Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Academic Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Food product 1.

Food product 2.

Food product 3.

Food product 4.

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in serum fructose between peak and baseline

Secondary Outcome Measures

Blood pressure
Millimeter of mercury
Serum uric acid
Millimoles per liter

Full Information

First Posted
March 28, 2023
Last Updated
April 12, 2023
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05826717
Brief Title
Effect of Matrices on Serum Fructose.
Official Title
Effects of the Food Matrix on Serum Fructose Peaks
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fructose Metabolism Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food product 1.
Arm Type
Experimental
Arm Description
[x] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Arm Title
Food product 2.
Arm Type
Experimental
Arm Description
[x] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Arm Title
Food product 3.
Arm Type
Experimental
Arm Description
[x] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time.
Arm Title
Food product 4.
Arm Type
Experimental
Arm Description
20 gr of fructose powder dissolved in 300 ml of water. Administered one time.
Intervention Type
Other
Intervention Name(s)
Apple
Intervention Description
20g fructose in [x] g of apple
Intervention Type
Other
Intervention Name(s)
Mashed apple
Intervention Description
20g fructose in [x] g of mashed apple
Intervention Type
Other
Intervention Name(s)
Apple juice
Intervention Description
20g fructose in [x] ml apple juice
Intervention Type
Other
Intervention Name(s)
Fructose powder in water
Intervention Description
20g fructose in [x] ml water
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Blood pressure
Description
Millimeter of mercury
Time Frame
Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
Title
Serum uric acid
Description
Millimoles per liter
Time Frame
Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Academic Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

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Effect of Matrices on Serum Fructose.

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