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Search / Trial NCT01363141

Effect of a Low Advanced Glycation End Products (AGE) Diet in the Metabolic Syndrome

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · May 31, 2011

Trial Information

Current as of June 12, 2025

Completed

Keywords

Cardiovascular Diseases Type 2 Diabetes Mellitus Abdominal Fat Atherogenic Dyslipidemia Hypertension Hyperglycemia Insulin Resistance Thrombosis State

ClinConnect Summary

The metabolic syndrome (MetSyn), a well-defined cluster of pathogenic conditions, includes glucose intolerance, insulin resistance (pre-diabetes), hypertension, abdominal obesity, and dyslipidemia. The MetSyn has a strong inflammatory component and raises the risk for cardiovascular disease (CVD) by five-fold and of diabetes by two fold in aging. Although, excessive caloric intake, i.e. "over nutrition" is known to be involved in developing the MetSyn, the actual causative agents of MetSyn in human nutrition have not been determined.

The investigators have previously shown that Advanced Gl...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Non-smoking adult subjects with at least three of the following five characteristics of the metabolic syndrome (MetSyn):
  • * Waist circumference:
  • Men: \> 102 cm Women: \> 88 cm
  • Blood pressure: \> 130/85 mm Hg (or use of anti-Blood Pressure medication)
  • * HDL-cholesterol:
  • Men: \< 40 mg/dL Women: \< 50 mg/dL
  • Triglycerides: \> 150 mg/dL (or use of medications for high triglycerides such as fibrates or nicotinic acid)
  • Fasting blood sugar \> 100 mg/dl (or use of metformin), but a Glycated hemoglobin (HbA1c) \<6.5%
  • Any gender and race 50 years old or above
  • Dietary AGE intake \> 12 AGE Eq/day
  • (Before randomization all participants will be screened with a 3-day food record and 7-day food frequency questionnaire (AGE Quick Score) to determine their average spontaneous daily intake of AGEs. Only those subjects whose daily intake is \> 12 AGE Eq/day will participate in the study.)
  • Exclusion Criteria:
  • Diagnosis of diabetes (HbA1C \> 6.5 %)
  • Glomerular Filtration Rate (GFR) less than 60 ml/min
  • Any major cardiovascular event within the preceding 3 months
  • Inability to understand or unwillingness to follow study diets
  • Any unstable medical condition requiring medication adjustment or treatment within the preceding 3 months
  • Any severe illness with an expected participant survival less than 1 year
  • Diagnosis of HIV
  • Currently receiving treatment for any inflammatory condition
  • Currently receiving cancer treatment, such as radiation, chemotherapy, hormone therapy, or stem cell transplant
  • Currently participating in any other research study requiring a special diet, medications, supplements or other lifestyle change

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

John C He, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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