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

NCT06005519 | Completed

• 1 other identifier: 480
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

Advanced glycation end products; diabetes; nutrition; diet

Outcome Measures

Primary Outcomes (12)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  90 days

Study Arms (2)

Type 2 diabetes

OTHER

Other: low AGE diet education

healthy participants

OTHER

Other: low AGE diet education

Interventions

low AGE diet education OTHER

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.

Type 2 diabetes; healthy participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have the competence to adhere to dietary recommendations

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Fatih, 34096, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 22, 2023
• Study Start: December 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

TU (1)