Advanced Glycation EndproductsNCT03866343
Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals
A study testing Diet low or high in advanced glycation endproducts in people with Advanced Glycation Endproducts and AGEs, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Current efforts to arrest the epidemic of type 2 diabetes mellitus (T2DM) have had limited success. Thus there is an urgent need for effective approaches to prevent the development of T2DM. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Glycation Endproducts, AGEs, Diet
- What is being tested?
- Diet low or high in advanced glycation endproducts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2018to 3 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Abdominal obesity: waist circumference for men ≥ 102 cm, and for women ≥ 88 cm.
- Aged 18 years and older
- Caucasian (because of skin fluorescence and capillary microscopy measurements)
Who cannot join
- Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
- Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
- Lipid lowering medication (e.g. statins)
- Use of medication known to influence glucose metabolism, vascular function and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID's)
- Inability to stop antihypertensive medication for 13 weeks. Exclusion of higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
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- Pulmonary or inflammatory disease
- Kidney failure or electrolyte disorders
- Pregnancy or lactation
- No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
- Known allergic reaction to ultrasound contrast-agent
- Smoking (active or cessation <1 year prior to screening date).
- High alcohol usage (>4 U/day) or drug abuse
- Use of dietary supplements or an investigation product within the previous month
- Significant food allergies/intolerance
- Vegetarianism
- Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- Participation in another biomedical trial during the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals: a Randomized Controlled Trial
Current efforts to arrest the epidemic of type 2 diabetes mellitus (T2DM) have had limited success. Thus there is an urgent need for effective approaches to prevent the development of T2DM. It is widely accepted that the current epidemic is driven by an increase in global food abundance and reduced food quality, making changes in diet a key determinant of the T2DM epidemic. Dietary factors can affect cardio-metabolic health; among these factors, advanced glycation end-products (AGEs) in food are potential risk factors for insulin resistance and T2DM.
AGEs are a heterogeneous group of unavoidable stable bioactive compounds. Endogenous formation of AGEs is a continuous naturally occurring process, and is the result of normal metabolism. However, increased formation of AGEs occurs during ageing and under hyperglycaemic conditions. AGEs are implicated in the development of diabetes and vascular complications.
Over the past several decades, methods of food processing have changed and meals now contain excess fat and sugar and are most susceptible for the formation of AGEs. In addition, AGEs in food are highly desirable due to their profound effect on shelf life, sterility, flavour, colour, and thus food consumption. Hence, a substantial portion of AGEs are derived from exogenous sources, particularly food. These exogenous AGEs are potential risk factors for insulin resistance and the development of T2DM. The investigators recently found that dietary AGEs represent a significant source of circulating AGEs, and have similar pathogenic properties compared to their endogenous counterparts including the development of insulin resistance and T2DM. Taken together, dietary AGEs are proposed to play a pivotal role in the development and progression of T2DM and its complications. Reduction of dietary intake of AGEs may therefore be an alternative strategy to reduce the risk of vascular disease and insulin resistance. The investigators therefore hypothesize that dietary restriction of AGEs in overweight individuals improves insulin sensitivity, β-cell function, and vascular function.
- Conditions
- Advanced Glycation Endproducts, AGEs, Diet, Insulin Sensitivity/Resistance, Beta-cell Function, Vascular Function
- Being tested
- Diet low or high in advanced glycation endproducts
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet low or high in advanced glycation endproductsOther
All subjects will undergo an intervention consisting of a prescribed diet containing either a low or high quantity of AGEs during 4 continuous weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low AGE diet | Active comparator | Subjects will be asked to consume a diet containing a low AGE content for 4 weeks. Receives: Other: Diet low or high in advanced glycation endproducts |
| High AGE diet | Other | Subjects will be asked to consume a diet containing a high AGE content for 4 weeks. Receives: Other: Diet low or high in advanced glycation endproducts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Assessed by hyperinsulinaemic-euglycaemic clamp
Measured: Difference after 4 weeks of intervention
Secondary outcomes (1)
Microvascular function
Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle
Measured: Difference after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start7 Sep 2018
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
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 Advanced Glycation EndproductsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 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
- NCT03866343
- Sponsor's protocol ID
- NL63215.068.17
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2019
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Linkens AM, Houben AJ, Niessen PM, Wijckmans NE, de Goei EE, Van den Eynde MD, Scheijen JL, van den Waarenburg MP, Mari A, Berendschot TT, Streese L, Hanssen H, van Dongen MC, van Gool CC, Stehouwer CD, Eussen SJ, Schalkwijk CG. A 4-week high-AGE diet does not impair glucose metabolism and vascular function in obese individuals. JCI Insight. 2022 Mar 22;7(6):e156950. doi: 10.1172/jci.insight.156950.
PubMed 35133989
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03866343
- Acronym / sponsor ID
- NL63215.068.17
- Conditions
- Advanced Glycation Endproducts, AGEs, Diet, Insulin Sensitivity/Resistance, Beta-cell Function, Vascular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 7 Mar 2019 (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.
Current efforts to arrest the epidemic of type 2 diabetes mellitus (T2DM) have had limited success. Thus there is an urgent need for effective approaches to prevent the development of T2DM. It is widely accepted that the current epidemic is driven by an increase in global food abundance and reduced food quality, making changes in diet a key determinant of the T2DM epidemic. Dietary factors can affect cardio-metabolic health; among these factors, advanced glycation end-products (AGEs) in food are potential risk factors for insulin resistance and T2DM.
AGEs are a heterogeneous group of unavoidable stable bioactive compounds. Endogenous formation of AGEs is a continuous naturally occurring process, and is the result of normal metabolism. However, increased formation of AGEs occurs during ageing and under hyperglycaemic conditions. AGEs are implicated in the development of diabetes and vascular complications.
Over the past several decades, methods of food processing have changed and meals now contain excess fat and sugar and are most susceptible for the formation of AGEs. In addition, AGEs in food are highly desirable due to their profound effect on shelf life, sterility, flavour, colour, and thus food consumption. Hence, a substantial portion of AGEs are derived from exogenous sources, particularly food. These exogenous AGEs are potential risk factors for insulin resistance and the development of T2DM. The investigators recently found that dietary AGEs represent a significant source of circulating AGEs, and have similar pathogenic properties compared to their endogenous counterparts including the development of insulin resistance and T2DM. Taken together, dietary AGEs are proposed to play a pivotal role in the development and progression of T2DM and its complications. Reduction of dietary intake of AGEs may therefore be an alternative strategy to reduce the risk of vascular disease and insulin resistance. The investigators therefore hypothesize that dietary restriction of AGEs in overweight individuals improves insulin sensitivity, β-cell function, and vascular function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low AGE diet | Active comparator | Other: Diet low or high in advanced glycation endproductsSubjects will be asked to consume a diet containing a low AGE content for 4 weeks. |
| High AGE diet | Other | Other: Diet low or high in advanced glycation endproductsSubjects will be asked to consume a diet containing a high AGE content for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Abdominal obesity: waist circumference for men ≥ 102 cm, and for women ≥ 88 cm.
- Aged 18 years and older
- Caucasian (because of skin fluorescence and capillary microscopy measurements)
Key exclusion criteria (18 listed)
- Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
- Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
- Lipid lowering medication (e.g. statins)
- Use of medication known to influence glucose metabolism, vascular function and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID's)
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 |
|---|---|---|
| Diet low or high in advanced glycation endproductsAll subjects will undergo an intervention consisting of a prescribed diet containing either a low or high quantity of AGEs during 4 continuous weeks. | Other | High AGE diet, Low AGE diet |
Primary outcome
Insulin sensitivity
Time frame: Difference after 4 weeks of intervention
Assessed by hyperinsulinaemic-euglycaemic clamp
1 secondary outcome
Microvascular function
Time frame: Difference after 4 weeks of intervention
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 8 Mar 2021.
- Derived from this study: PubMed 35133989Linkens AM, Houben AJ, Niessen PM, Wijckmans NE, de Goei EE, Van den Eynde MD, Scheijen JL, van den Waarenburg MP, Mari A, Berendschot TT, Streese L, Hanssen H, van Dongen MC, van Gool CC, Stehouwer CD, Eussen SJ, Schalkwijk CG. A 4-week high-AGE diet does not impair glucose metabolism and vascular function in obese individuals. JCI Insight. 2022 Mar 22;7(6):e156950. doi: 10.1172/jci.insight.156950.
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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 Diet low or high in advanced glycation endproducts in people with Advanced Glycation Endproducts and AGEs, 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 3 inclusion and 18 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 8 Mar 2021. 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?
Insulin sensitivity (time frame: Difference after 4 weeks of intervention). 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 NCT03866343, 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 Mar 2021.