The Effects of Restricted Dietary of Advanced Glycation End Products(AGEs) on the Glycemic Control, Oxidative Stress and Systemic-inflammation in Patients With Metabolic.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Serum Levels of carboxymethyl-lysine(CML)
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
AGEs restricted diet
Low calorie diet + AGEs restricted diet
Intervention: AGEs restricted diet (Other)
control
Low calorie diet
Outcomes
Primary Outcomes
Serum Levels of carboxymethyl-lysine(CML)
Time Frame: 8 weeks
specific serum AGEs
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Azita Hekmatdoost
Principal Investigator
National Nutrition and Food Technology Institute