Type 2 DiabetesERIENCT05717608
Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes
A study testing high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects in people with Type 2 Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2023to 30 Apr 2026
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 T2D patients (20 Caucasian and 20 SAS)
- 40-70 years old
- Male-female
- BMI 25-35 kg/m2
- Stable anti diabetic drugs for 3 months (metformin is obligatory)
- Stable medication use past 3 months
- Able to give informed consent
Who cannot join
- - Proton-pump inhibitor usage (known to effect gut microbiota)
- GLP1, SGLT2i or insulin use (known to effect gut microbiota)
- Antibiotic for the past 3 months (known to effect gut microbiota)
- Probiotic or symbiotic usage (known to effect gut microbiota)
- Pregnant women
- Chronic illness (including a known history of heart failure, renal failure (eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
Show all 13Show fewer
- Active infection
- Previous intestinal (e.g., bowel resection/reconstruction) surgery
- Smoking (due to its influence on gut microbiome)
- Vegetarian diet (since they have different microbiota)
- >6 alcohol units per day or >14 alcohol units per week
- Active malignancy
- HbA1c >9% (75mmol/mol)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam
max nieuwdorp, MD PhD, 0031 20 5669111, m.nieuwdorp@amsterdamumc.nl
About this study
Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.
Read the detailed description
The prevalence and accompanying morbidity and mortality of obesity and type 2 diabetes (T2D) is increasing on a global scale. Unfortunately the underlying (patho)physiological mechanisms are only partially understood. A key step in the development of negative health effects of metabolic disease might be via dietary fructose metabolism and its accompanying aberrant metabolite production, in which our gut microbiota plays a crucial role.
By bypassing the normal glucose metabolism pathway, fructose plays a role in the development of metabolic disease such as diabetes en fatty liver disease. The mechanism of this effect is unclear and possibly plays in the observation of ethnic specific metabolic risk factors. That is, subjects of different ethnicties (for instance South-Asian Surinamese (SAS)) have a higher risk and worse trajectory of metabolic diseases than Caucasians. Since gut microbiota is altered between these two ethnicities, we hypothesize that aberreant fructose catabolism in patients of SAS descent results in production of specific (gut microbiota derived) metabolites such as ethanol. In this study, fructose metabolism will thus be studied in patients of SAS and Caucasian Dutch descent. To this end the investigators will examine (13C stable isotope based) fructose fluxes before and after randomizing subjects into a four-week high- or low fructose diet. This study aims to elucidate the physiological and microbial catabolism of fructose and possible differences between these two ethnicities.
- Conditions
- Type 2 Diabetes
- Being tested
- high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectsOther
oral ingestion of food supplement for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| high fructose in caucasian dutch type 2 diabetes subjects | Active comparator | high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity. Receives: Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects |
| low fructose in caucasian dutch type 2 diabetes subjects | Placebo comparator | low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity. Receives: Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects |
| high fructose in surinamese asian type 2 diabetes | Active comparator | high (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of SAS ethnicity. Receives: Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects |
| low fructose in surinamese asian type 2 diabetes | Placebo comparator | low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of SAS ethnicity. Receives: Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
fructose on glucose metabolism
to correlate changes in oral fructose handling (measured by a fructose challenge test (AUC) with 13C6-labeled fructose in relation to metabolic effects on HOMA-IR and continuous glucose monitoring (Freestyle libre MAGE) at baseline and after 4 weeks of dietary intervention.
Measured: 4 weeks
Secondary outcomes (2)
changes in microbiota composition
correlate with changes in oral/fecal microbiota composition (diversity and strain)
Measured: 4 weeks
changes in (postprandial )plasma metabolites
effects of the diet on body composition (measured via bio impedance analysis). We will also collects 24h feces and urine before each study visit to determine correlate with changes in (postprandial) untargeted plasma metabolites including endogenous ethanol
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Feb 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- high versus low fructose diet for 4 weeks in either caucasian or surinamese asian type 2 diabetes patients
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- max nieuwdorp, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717608
- Sponsor's protocol ID
- 2022.0606 - NL82353.018.22
- Acronym
- ERIE
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed due to dutch GDPR regulations
Publications
Westerbeke FHM, Rios-Morales M, Attaye I, Nieuwdorp M. Fructose catabolism and its metabolic effects: Exploring host-microbiota interactions and the impact of ethnicity. J Physiol. 2025 Dec;603(24):7661-7681. doi: 10.1113/JP287316. Epub 2025 Jan 13.
PubMed 39805044
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Dietary Fructose on Fructose Kinetics in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05717608
- Acronym / sponsor ID
- ERIE / 2022.0606 - NL82353.018.22
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Feb 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.
Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.
Detailed description
The prevalence and accompanying morbidity and mortality of obesity and type 2 diabetes (T2D) is increasing on a global scale. Unfortunately the underlying (patho)physiological mechanisms are only partially understood. A key step in the development of negative health effects of metabolic disease might be via dietary fructose metabolism and its accompanying aberrant metabolite production, in which our gut microbiota plays a crucial role.
By bypassing the normal glucose metabolism pathway, fructose plays a role in the development of metabolic disease such as diabetes en fatty liver disease. The mechanism of this effect is unclear and possibly plays in the observation of ethnic specific metabolic risk factors. That is, subjects of different ethnicties (for instance South-Asian Surinamese (SAS)) have a higher risk and worse trajectory of metabolic diseases than Caucasians. Since gut microbiota is altered between these two ethnicities, we hypothesize that aberreant fructose catabolism in patients of SAS descent results in production of specific (gut microbiota derived) metabolites such as ethanol. In this study, fructose metabolism will thus be studied in patients of SAS and Caucasian Dutch descent. To this end the investigators will examine (13C stable isotope based) fructose fluxes before and after randomizing subjects into a four-week high- or low fructose diet. This study aims to elucidate the physiological and microbial catabolism of fructose and possible differences between these two ethnicities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- high versus low fructose diet for 4 weeks in either caucasian or surinamese asian type 2 diabetes patients
| Arm | Type | Receives |
|---|---|---|
| high fructose in caucasian dutch type 2 diabetes subjects | Active comparator | Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectshigh (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity. |
| low fructose in caucasian dutch type 2 diabetes subjects | Placebo comparator | Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectslow fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of Caucasian ethnicity. |
| high fructose in surinamese asian type 2 diabetes | Active comparator | Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectshigh (100gr/day) fructose diet for 4 weeks in type 2 diabetic subjects of SAS ethnicity. |
| low fructose in surinamese asian type 2 diabetes | Placebo comparator | Other: high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectslow fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks in type 2 diabetic subjects of SAS ethnicity. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 T2D patients (20 Caucasian and 20 SAS)
- 40-70 years old
- Male-female
- BMI 25-35 kg/m2
- Stable anti diabetic drugs for 3 months (metformin is obligatory)
Key exclusion criteria (13 listed)
- - Proton-pump inhibitor usage (known to effect gut microbiota)
- GLP1, SGLT2i or insulin use (known to effect gut microbiota)
- Antibiotic for the past 3 months (known to effect gut microbiota)
- Probiotic or symbiotic usage (known to effect gut microbiota)
- Pregnant women
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 |
|---|---|---|
| high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjectsoral ingestion of food supplement for 4 weeks | Other | high fructose in caucasian dutch type 2 diabetes subjects, high fructose in surinamese asian type 2 diabetes, low fructose in caucasian dutch type 2 diabetes subjects, low fructose in surinamese asian type 2 diabetes |
Primary outcome
fructose on glucose metabolism
Time frame: 4 weeks
to correlate changes in oral fructose handling (measured by a fructose challenge test (AUC) with 13C6-labeled fructose in relation to metabolic effects on HOMA-IR and continuous glucose monitoring (Freestyle libre MAGE) at baseline and after 4 weeks of dietary intervention.
2 secondary outcomes
changes in microbiota composition
Time frame: 4 weeks
changes in (postprandial )plasma metabolites
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39805044Westerbeke FHM, Rios-Morales M, Attaye I, Nieuwdorp M. Fructose catabolism and its metabolic effects: Exploring host-microbiota interactions and the impact of ethnicity. J Physiol. 2025 Dec;603(24):7661-7681. doi: 10.1113/JP287316. Epub 2025 Jan 13.
- Individual participant dataSharing planned: No. not allowed due to dutch GDPR regulations
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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.
max nieuwdorp principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high vs low fructose in caucasian dutch or surinamese asian type 2 diabetes subjects in people with Type 2 Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cengiz callender, MD (0031 20 5669111, c.callender@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fructose on glucose metabolism (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717608, which also lists 1 linked publication.
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 8 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.