Type 2 DiabetesNCT07303842
Effect of a Low Advanced Glycation End Products Diet of Patients With Type 2 Diabetes Mellitus
A study testing a low-CML diet in people with Type 2 Diabetes and Coronary Artery Disease (CAD), run by InCor Heart Institute at 1 site in Brazil.
Trial summary
The present study showed that a reduction of approximately 56% in CML consumption promoted a 30% reduction in this blood biomarker. This effect was associated with increased fiber intake and reduced consumption of polyunsaturated fatty acids, trans fatty acids, and cholesterol, in addition to a positive linear… Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Coronary Artery Disease (CAD)
- What is being tested?
- a low-CML diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Mar 2022to 1 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with the following diagnoses were excluded: insulin-dependent diabetes mellitus, renal insufficiency, hepatic insufficiency, eating disorders such as binge eating, depression, and/or anxiety. In addition, patients who were eutrophic, with a body mass index (BMI) were excluded. Smokers, patients who consumed alcoholic beverages, used nutritional supplements, or had a plant-based dietary pattern were also excluded. Likewise, patients who were participating in other research protocols or who did not complete and sign the informed consent form (ICF) were excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Servico de Prevencao, Cardiopatia na Mulher e Reabilitacao Cardiovascular, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP,
São Paulo, São Paulo, 05403- 900
About this study
Official title: Effect of a Low Advanced Glycation End Products Diet Blood Biomarkers of Patients With Type 2 Diabetes Mellitus: Randomized Controlled Trial.
The present study showed that a reduction of approximately 56% in CML consumption promoted a 30% reduction in this blood biomarker. This effect was associated with increased fiber intake and reduced consumption of polyunsaturated fatty acids, trans fatty acids, and cholesterol, in addition to a positive linear correlation with lipid peroxidation, body water, and dPFGAs. This represents a potential benefit, given that these factors favor insulin resistance (IR) and vascular endothelial injury, and consequently, the processes of diabetes and atherosclerosis. Thus, reducing the daily consumption of CML in the diet, combined with preparing foods at lower temperatures, constitutes a potentially protective nutritional intervention in the context of diabetes and, especially, vascular health, with a plausible impact on the prevention of cardiometabolic complications. It is worth noting that future research for analyses of total PFGAs, specific PFGAs such as pyrraline and pentosidine, and with dPFGAs, and/or studies involving a table of dietary PFGA composition with foods of Brazilian origin are necessary due to their importance in the public health context in Brazil. Furthermore, the need for long-term studies on restricting PFGA consumption is highlighted.
- Conditions
- Type 2 Diabetes, Coronary Artery Disease (CAD)
- Being tested
- a low-CML diet, Control
- Keywords
- Carboxymethyllysine, Advanced glycation end products in food, Type 2 diabetes mellitus, Coronary artery disease, Randomized clinical trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a low-CML dietOther
Patients were instructed to boil or cook their food, and to avoid frying, grilling, and roasting. The assessment of CML content, as well as adherence to the dietary intervention, was based on the average of the 24-Hour Recalls (R24H) and was calculated based on the previous study conducted by Uribarri and collaborators, who evaluated 549 foods, with results published in 2010. The authors estimated that 1 AGE equals 1,000 KU (kilo-units). Considering that the study was conducted with an American population, certain regional foods were not found in the table; therefore, foods with similar composition were used to quantify CML.
ControlOther
Patients on their usual diet
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Other: Control |
| Intervention group | Active comparator | Not described Receives: Other: a low-CML diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM.
Quantification of serum CML was performed using the OxiSelectTM Nε-(carboxymethyl) lysine Competitive ELISA kit (Cell Biolabs®), following the manufacturer's instructions.
Measured: Right after the blood collection
Secondary outcomes (2)
To evaluate the effect of CML reduction on body composition, through anthropometric and bioimpedance measurements.
For the anthropometric assessment, the following variables were used: weight, height, BMI, waist and abdomen circumference. BMI, waist-to-height ratio (WHtR), and abdominal circumference were assessed according to the World Health Organization (WHO). All circumferences were performed in triplicate. Determination of body composition was performed by bioelectrical impedance analysis (BIA) using the Tanita Corporation® (BC601 2018-2020, Maeno-cho Itabashi ku, Tokyo, Japan).
Measured: 30 minutes, during the consultation on the first evaluation day and on Day 15 afterward.
To evaluate the influence of reduced CML levels on the serum concentrations of glucose, insulin, triglycerides, HDL (High-Density Lipoprotein), and LDL (Low-Density Lipoprotein).
The dosages of glucose,, LDL, HDL, and triglycerides were performed using a colorimetric assay on an automated Alinity C analyzer (Abbott, TX, USA), utilizing specific kits.
Insulin dosages were performed by chemiluminescence on an automated Alinity I analyzer (Abbott), utilizing specific kits.
Measured: Right after the blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Mar 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANTONIO DE PADUA MANSUR, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303842
- Sponsor's protocol ID
- 52932821.9.0000.0068
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low Advanced Glycation End Products Diet Blood Biomarkers of Patients With Type 2 Diabetes Mellitus: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07303842
- Acronym / sponsor ID
- 52932821.9.0000.0068
- Conditions
- Type 2 Diabetes, Coronary Artery Disease (CAD)
- Keywords
- Carboxymethyllysine, Advanced glycation end products in food, Type 2 diabetes mellitus, Coronary artery disease, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 26 Dec 2025 (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.
The present study showed that a reduction of approximately 56% in CML consumption promoted a 30% reduction in this blood biomarker. This effect was associated with increased fiber intake and reduced consumption of polyunsaturated fatty acids, trans fatty acids, and cholesterol, in addition to a positive linear correlation with lipid peroxidation, body water, and dPFGAs. This represents a potential benefit, given that these factors favor insulin resistance (IR) and vascular endothelial injury, and consequently, the processes of diabetes and atherosclerosis. Thus, reducing the daily consumption of CML in the diet, combined with preparing foods at lower temperatures, constitutes a potentially protective nutritional intervention in the context of diabetes and, especially, vascular health, with a plausible impact on the prevention of cardiometabolic complications. It is worth noting that future research for analyses of total PFGAs, specific PFGAs such as pyrraline and pentosidine, and with dPFGAs, and/or studies involving a table of dietary PFGA composition with foods of Brazilian origin are necessary due to their importance in the public health context in Brazil. Furthermore, the need for long-term studies on restricting PFGA consumption is highlighted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control |
| Intervention group | Active comparator | Other: a low-CML diet |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with the following diagnoses were excluded: insulin-dependent diabetes mellitus, renal insufficiency, hepatic insufficiency, eating disorders such as binge eating, depression, and/or anxiety. In addition, patients who were eutrophic, with a body mass index (BMI) were excluded. Smokers, patients who consumed alcoholic beverages, used nutritional supplements, or had a plant-based dietary pattern were also excluded. Likewise, patients who were participating in other research protocols or who did not complete and sign the informed consent form (ICF) were excluded.
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 |
|---|---|---|
| a low-CML dietPatients were instructed to boil or cook their food, and to avoid frying, grilling, and roasting. The assessment of CML content, as well as adherence to the dietary intervention, was based on the average of the 24-Hour Recalls (R24H) and was calculated based on the previous study conducted by Uribarri and collaborators, who evaluated 549 foods, with results published in 2010. The authors estimated that 1 AGE equals 1,000 KU (kilo-units). Considering that the study was conducted with an American population, certain regional foods were not found in the table; therefore, foods with similar composition were used to quantify CML. | Other | Intervention group |
| ControlPatients on their usual diet | Other | Control group |
Primary outcome
To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM.
Time frame: Right after the blood collection
Quantification of serum CML was performed using the OxiSelectTM Nε-(carboxymethyl) lysine Competitive ELISA kit (Cell Biolabs®), following the manufacturer's instructions.
2 secondary outcomes
To evaluate the effect of CML reduction on body composition, through anthropometric and bioimpedance measurements.
Time frame: 30 minutes, during the consultation on the first evaluation day and on Day 15 afterward.
To evaluate the influence of reduced CML levels on the serum concentrations of glucose, insulin, triglycerides, HDL (High-Density Lipoprotein), and LDL (Low-Density Lipoprotein).
Time frame: Right after the blood collection
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 26 Dec 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 a low-CML diet in people with Type 2 Diabetes and Coronary Artery Disease (CAD), run by InCor Heart Institute at 1 site in Brazil.
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 0 inclusion and 1 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 26 Dec 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 Brazil. 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?
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?
To evaluate the effect of the low-CML diet on the percentage reduction of serum CML in patients with T2DM. (time frame: Right after the blood collection). 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 26 Dec 2025.