The Effects of Restricted Dietary of AGEs on the Glycemic Control, Oxidative Stress and Inflammation

Metabolic Syndrome Clinical Trial

— AGEs  

Official title:

The Effects of Restricted Dietary of Advanced Glycation End Products(AGEs) on the Glycemic Control, Oxidative Stress and Systemic-inflammation in Patients With Metabolic.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147339
• Other study ID #: NNFTRI691
• Status: Completed
• Phase: N/A
• First received: April 30, 2017
• Last updated: September 18, 2017
• Start date: January 10, 2017
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of dietary restriction of advanced glycated end products (AGEs) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.Both groups will be advised to follow same low energy diet and no changing in physical activity pattern.Parameters related to metabolic syndrome, anthropocentric factors, oxidative stress(Malondialdehyde), CML(AGEs factor in blood) and systemic inflammation factors (hs-CRP وTNF-α ) will be measured at the baseline and at the end of the study.

Description:

Metabolic syndrome (MS) is a cluster of cardiovascular risk factor abnormalities associated with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause mortality. Non-enzymatic glycation plays an important role in the development of physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and chronic renal failure. Preventing glycation can minimize diabetic complications. Advanced glycation end products (AGEs) are formed endogenously when the carbonyl groups of reducing sugars nonenzymatically react with the free amino groups on proteins. AGEs are generated in vivo as a normal consequence of metabolism, but their formation is accelerated under conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. It can also form in food processing and the variety and the amount of dietary AGEs (dAGE) depend on food nutrients, the heating used in food processing, pH conditions, presence of some metal ions (Cu++, Fe++) and water content. In this study 2 groups of metabolic syndrome patients(22 in each group) will receive same low calorie diet and one of the groups plus restricted dietary AGEs according to the international references.Along 8 weeks the investigators will talk to each patient by phone and every months the participants will come and the investigators will take anthropocentric measurements and the recommendations for diets will review. The three-day 24-hour recall food questionnaire will take at first,middle and the end of program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years of age

• having three of the following five features: Increased waist circumference (=102 cm in men and =88 cm in women), elevated TG (=150 mg/dl), reduced HDL-C (=40 mg/dl in men and =50 mg/dl in women), elevated blood pressure (=130/85 mm Hg or on treatment for hypertension) and elevated glucose (=100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report

Exclusion Criteria:

• history of allergy

• clinically diagnosed renal, pituitary, thyroid, infections and inflammations, cancer and using of insulin, using multivitamin mineral and vitamin B6 suplements.

• Using any

• history of cancers.

• pregnancy, lactation.

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• AGEs restricted diet
Diet modification to reduce advanced glycation end products in diet. for example to change ways of cooking, time of cooking and also omit some foods.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Dr Azita Hekmatdoost

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Levels of carboxymethyl-lysine(CML)	specific serum AGEs	8 weeks