Diabetes Type 2AGENCT06005519
The Short and Long-term Effects of Low Advanced Glycation End Product* Diet
A study testing low AGE diet education in people with Diabetes Type 2, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the hypothesis that a diet low in advanced glycation end products (AGE) would provide short and long term improvement in metabolic and inflammatory parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- low AGE diet education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 30 Aug 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have the competence to adhere to dietary recommendations
Who cannot join
- Being <18 years old or >65 years old
- Having a history of serious cardiovascular diseases (atrial fibrillation, stroke, ischemic heart disease, peripheral vascular disease, heart failure)
- Having chronic obstructive pulmonary disease
- Smoking
- Having kidney or liver failure
- Having a chronic gastrointestinal disease associated with malabsorption or chronic pancreatitis
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- Having a history of rheumatological disease
- Having a history of severe acute illness, malignancy, or alcohol abuse in the last 1 month
- Receiving immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty
Istanbul, Fatih, 34096
About this study
Official title: The Short and Long-term Effects of Low AGE Diet on Individuals With and Without Type 2 Diabetes
The aim of this study was to examine the hypothesis that a diet low in advanced glycation end products (AGE) would provide short and long term improvement in metabolic and inflammatory parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in individuals with type 2 diabetes. Specifically, in order to observe the effect of AGE content on the results, diabetic patients who are followed up and who know the principles of low glycaemic index and glycaemic load nutrition suitable for diabetic patients, who do not have additional diseases and who do not smoke were selected.
In recent years, it has been determined that AGE accumulation in the tissue has an effect on the pathophysiology of many diseases such as Alzheimer's disease as well as chronic complications of diabetes. However, the contribution of dietary AGE intake to this pool is controversial. There are studies with conflicting results in the literature on whether a low AGE diet is effective on metabolic and biochemical well-being. In addition, studies investigating the effects of reducing AGE content in the diet of people with no chronic disease are limited.
In this study, the metabolic results of dietary modification in the short term of 2 weeks and in the long term of 3 months are determined. In addition, the results are analysed separately in type 2 diabetic and non-diabetic groups. Thus, the data showing the short and long term metabolic effects of dietary AGE levels for diabetic and non-diabetic patients will contribute to the literature.
Read the detailed description
The study included 30 volunteers with type 2 diabetes and 30 healthy participants. During the initial interviews, participants were provided with training on low AGE (advanced glycation end-products) dietary principles. In the same session, measurements were taken and recorded for height, body weight, blood pressure, waist and hip circumference, and body fat percentage. Fasting blood glucose, HbA1c, c-peptide, C reactive protein (CRP), insulin, blood lipid levels, 1-5 anhydroglucitol (1-5 AG), AGE, Soluble AGE Receptor (sRAGE) , methylglyoxal (MG) and carboxymethyllysine (CML) levels were measured through blood samples.
Participants were asked to maintain a dietary journal and were followed up through weekly online or face-to-face meetings. They were called in for a follow-up examination 2 weeks and 3 months after the initial interview. Anthropometric measurements and blood tests were repeated.
After the completion of a 3-month follow-up for all participants, measurements from both the short and long term resulting from the low AGE diet were analyzed by comparing them to the initial measurements, both for participants with and without diabetes.
- Conditions
- Diabetes Type 2
- Being tested
- low AGE diet education
- Keywords
- Advanced glycation end products, diabetes, nutrition, diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low AGE diet educationOther
Participants were divided into ten-person groups. Each group was individually invited for a face-to-face meeting where they were provided with a 50-minute low-AGE diet education prepared in accordance with the recommendations of the American Diabetes Association and the Turkish Society of Endocrinology and Metabolism. During the first 20 minutes of the education, a PowerPoint presentation highlighted the importance of choosing plant-based, low-AGE foods and emphasized cooking methods such as boiling, steaming, and preparing meals with added liquids. Participants were advised against frying, roasting, and grilling. Additionally, information was provided on marinade techniques and the use of spices or ingredients such as lemon or vinegar to lower pH in meals. Following the education, participants were given a dietary diary to record their food intake and were asked to self-assess their diet adherence on a scale of 1 to 10 on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Other | Not described Receives: Other: low AGE diet education |
| healthy participants | Other | Not described Receives: Other: low AGE diet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum AGE levels in short time period
After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
Measured: 14 days
Change in serum AGE levels in long time period
After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
Measured: 90 days
change in body weight in short time period
After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups
Measured: 14 days
Change in body weight in long time period
After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups
Measured: 90 days
change in body mass index in short time period
After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups
Measured: 14 days
change in body mass index in long time period
After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups
Measured: 90 days
change in waist circumference in short time period
After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
Measured: 14 days
change in waist circumference in long time period
After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
Measured: 90 days
change in hip circumference in short time period
After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
Measured: 14 days
change in hip circumference in long time period
After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
Measured: 90 days
change in body fat percentage in short time period
After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
Measured: 14 days
change in body fat percentage in long time period
After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Dec 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğu Usanma Koban, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005519
- Sponsor's protocol ID
- 480
- Acronym
- AGE
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 22 Aug 2023
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short and Long-term Effects of Low AGE Diet on Individuals With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06005519
- Acronym / sponsor ID
- AGE / 480
- Conditions
- Diabetes Type 2
- Keywords
- Advanced glycation end products, diabetes, nutrition, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Aug 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.
The aim of this study was to examine the hypothesis that a diet low in advanced glycation end products (AGE) would provide short and long term improvement in metabolic and inflammatory parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in individuals with type 2 diabetes. Specifically, in order to observe the effect of AGE content on the results, diabetic patients who are followed up and who know the principles of low glycaemic index and glycaemic load nutrition suitable for diabetic patients, who do not have additional diseases and who do not smoke were selected.
In recent years, it has been determined that AGE accumulation in the tissue has an effect on the pathophysiology of many diseases such as Alzheimer's disease as well as chronic complications of diabetes. However, the contribution of dietary AGE intake to this pool is controversial. There are studies with conflicting results in the literature on whether a low AGE diet is effective on metabolic and biochemical well-being. In addition, studies investigating the effects of reducing AGE content in the diet of people with no chronic disease are limited.
In this study, the metabolic results of dietary modification in the short term of 2 weeks and in the long term of 3 months are determined. In addition, the results are analysed separately in type 2 diabetic and non-diabetic groups. Thus, the data showing the short and long term metabolic effects of dietary AGE levels for diabetic and non-diabetic patients will contribute to the literature.
Detailed description
The study included 30 volunteers with type 2 diabetes and 30 healthy participants. During the initial interviews, participants were provided with training on low AGE (advanced glycation end-products) dietary principles. In the same session, measurements were taken and recorded for height, body weight, blood pressure, waist and hip circumference, and body fat percentage. Fasting blood glucose, HbA1c, c-peptide, C reactive protein (CRP), insulin, blood lipid levels, 1-5 anhydroglucitol (1-5 AG), AGE, Soluble AGE Receptor (sRAGE) , methylglyoxal (MG) and carboxymethyllysine (CML) levels were measured through blood samples.
Participants were asked to maintain a dietary journal and were followed up through weekly online or face-to-face meetings. They were called in for a follow-up examination 2 weeks and 3 months after the initial interview. Anthropometric measurements and blood tests were repeated.
After the completion of a 3-month follow-up for all participants, measurements from both the short and long term resulting from the low AGE diet were analyzed by comparing them to the initial measurements, both for participants with and without diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | Other | Other: low AGE diet education |
| healthy participants | Other | Other: low AGE diet education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To have the competence to adhere to dietary recommendations
Key exclusion criteria (9 listed)
- Being <18 years old or >65 years old
- Having a history of serious cardiovascular diseases (atrial fibrillation, stroke, ischemic heart disease, peripheral vascular disease, heart failure)
- Having chronic obstructive pulmonary disease
- Smoking
- Having kidney or liver failure
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 |
|---|---|---|
| low AGE diet educationParticipants were divided into ten-person groups. Each group was individually invited for a face-to-face meeting where they were provided with a 50-minute low-AGE diet education prepared in accordance with the recommendations of the American Diabetes Association and the Turkish Society of Endocrinology and Metabolism. During the first 20 minutes of the education, a PowerPoint presentation highlighted the importance of choosing plant-based, low-AGE foods and emphasized cooking methods such as boiling, steaming, and preparing meals with added liquids. Participants were advised against frying, roasting, and grilling. Additionally, information was provided on marinade techniques and the use of spices or ingredients such as lemon or vinegar to lower pH in meals. Following the education, participants were given a dietary diary to record their food intake and were asked to self-assess their diet adherence on a scale of 1 to 10 on a weekly basis. | Other | Type 2 diabetes, healthy participants |
Primary outcome
Change in serum AGE levels in short time period
Time frame: 14 days
After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
Change in serum AGE levels in long time period
Time frame: 90 days
After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
change in body weight in short time period
Time frame: 14 days
After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups
Change in body weight in long time period
Time frame: 90 days
After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups
change in body mass index in short time period
Time frame: 14 days
After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups
change in body mass index in long time period
Time frame: 90 days
After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups
change in waist circumference in short time period
Time frame: 14 days
After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
change in waist circumference in long time period
Time frame: 90 days
After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
change in hip circumference in short time period
Time frame: 14 days
After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
change in hip circumference in long time period
Time frame: 90 days
After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
change in body fat percentage in short time period
Time frame: 14 days
After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
change in body fat percentage in long time period
Time frame: 90 days
After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
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 22 Aug 2023.
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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 low AGE diet education in people with Diabetes Type 2, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 22 Aug 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 Turkey (Türkiye). 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 AGE levels in short time period (time frame: 14 days). The study lists 12 primary outcomes in all. 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 22 Aug 2023.