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The Short and Long-term Effects of Low Advanced Glycation End Product* Diet (AGE)

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
low AGE diet education
Sponsored by
Marmara University Pendik Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Type 2 focused on measuring Advanced glycation end products, diabetes, nutrition, diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To have the competence to adhere to dietary recommendations Exclusion Criteria: 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 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

Sites / Locations

  • Istanbul University Istanbul Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Type 2 diabetes

healthy participants

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 21, 2023
Sponsor
Marmara University Pendik Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06005519
Brief Title
The Short and Long-term Effects of Low Advanced Glycation End Product* Diet
Acronym
AGE
Official Title
The Short and Long-term Effects of Low AGE Diet on Individuals With and Without Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University Pendik Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
Advanced glycation end products, diabetes, nutrition, diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 diabetes
Arm Type
Other
Arm Title
healthy participants
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
low AGE diet education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum AGE levels in short time period
Description
After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
Time Frame
14 days
Title
Change in serum AGE levels in long time period
Description
After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
Time Frame
90 days
Title
change in body weight in short time period
Description
After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups
Time Frame
14 days
Title
Change in body weight in long time period
Description
After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups
Time Frame
90 days
Title
change in body mass index in short time period
Description
After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups
Time Frame
14 days
Title
change in body mass index in long time period
Description
After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups
Time Frame
90 days
Title
change in waist circumference in short time period
Description
After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
Time Frame
14 days
Title
change in waist circumference in long time period
Description
After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
Time Frame
90 days
Title
change in hip circumference in short time period
Description
After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
Time Frame
14 days
Title
change in hip circumference in long time period
Description
After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
Time Frame
90 days
Title
change in body fat percentage in short time period
Description
After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
Time Frame
14 days
Title
change in body fat percentage in long time period
Description
After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To have the competence to adhere to dietary recommendations Exclusion Criteria: 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 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
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34096
Country
Turkey

12. IPD Sharing Statement

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The Short and Long-term Effects of Low Advanced Glycation End Product* Diet

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