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

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

The investigators have previously demonstrated that Advanced Glycation End products (AGEs) are associated with several chronic diseases in humans and that blood AGE levels can be significantly reduced by simply changing the way food is cooked. This is an interventional-randomized study in which we are trying to determine whether a diet low in AGE followed for 1 year can effectively reduce circulating AGE levels as well as markers of the metabolic syndrome in a group of patients with these abnormal markers.

Key facts

Study ID

NCT01363141

Run by

Icahn School of Medicine at Mount Sinai

People needed

383

Starts

2010-12-01

Expected to finish

2014-12-01

Last updated by the study team

2015-05-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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