Fructose Metabolism DisorderNCT05826717
Effect of Matrices on Serum Fructose.
A study testing Apple, Mashed apple and Apple juice in people with Fructose Metabolism Disorder, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fructose Metabolism Disorder
- What is being tested?
- Apple, Mashed apple and Apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Body mass index (BMI) ≥18.5 kg/m2 and <25 kg/m2
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Food Matrix on Serum Fructose Peaks
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.
- Conditions
- Fructose Metabolism Disorder
- Being tested
- Apple, Mashed apple, Apple juice, Fructose powder in water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppleOther
20g fructose in [x] g of apple
Mashed appleOther
20g fructose in [x] g of mashed apple
Apple juiceOther
20g fructose in [x] ml apple juice
Fructose powder in waterOther
20g fructose in [x] ml water
| Study group | Role | What they receive |
|---|---|---|
| Food product 1. | Experimental | [x] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. Receives: Other: Apple |
| Food product 2. | Experimental | [x] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. |
| Food product 3. | Experimental | [x] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time. Receives: Other: Apple juice |
| Food product 4. | Experimental | 20 gr of fructose powder dissolved in 300 ml of water. Administered one time. Receives: Other: Fructose powder in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum fructose between peak and baseline
Measured: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
Secondary outcomes (2)
Blood pressure
Millimeter of mercury
Measured: 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
Measured: Time points 0, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes following consumption of the food product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Dec 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fructose Metabolism DisorderStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826717
- Sponsor's protocol ID
- NL81668.068.22
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Food Matrix on Serum Fructose Peaks
- ClinicalTrials.gov ID
- NCT05826717
- Acronym / sponsor ID
- NL81668.068.22
- Conditions
- Fructose Metabolism Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is an open-label, randomized, single meal, cross-over study in healthy individuals.
| Arm | Type | Receives |
|---|---|---|
| Food product 1. | Experimental | Other: Apple[x] gr apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. |
| Food product 2. | Experimental | –[x] gr mashed apple containing 20 gr fructose as measured with an enzymatic method. Administered one time. |
| Food product 3. | Experimental | Other: Apple juice[x] ml apple juice containing 20 gr fructose as measured with an enzymatic method. Administered one time. |
| Food product 4. | Experimental | Other: Fructose powder in water20 gr of fructose powder dissolved in 300 ml of water. Administered one time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Body mass index (BMI) ≥18.5 kg/m2 and <25 kg/m2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple20g fructose in [x] g of apple | Other | Food product 1. |
| Mashed apple20g fructose in [x] g of mashed apple | Other | – |
| Apple juice20g fructose in [x] ml apple juice | Other | Food product 3. |
| Fructose powder in water20g fructose in [x] ml water | Other | Food product 4. |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple, Mashed apple and Apple juice in people with Fructose Metabolism Disorder, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.