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

NCT03147339 | Completed DMC

• 1 other identifier: NNFTRI691
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

AGEs( Advanced glycation end products)

Outcome Measures

Primary Outcomes (1)

• Serum Levels of carboxymethyl-lysine(CML)

  specific serum AGEs

  8 weeks

Study Arms (2)

AGEs restricted diet

EXPERIMENTAL

Low calorie diet + AGEs restricted diet

Other: AGEs restricted diet

control

NO INTERVENTION

Low calorie diet

Interventions

AGEs restricted diet OTHER

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.

AGEs restricted diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Azita Hekmatdoost: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehrān, Tehran Province, 19395-4741, Iran

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• National Nutrition and Food Technology Research Institute

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 10, 2017
• Study Start: January 10, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)