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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01363141
First received: May 27, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Other: Regular AGE Diet
Other: Low AGE Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Glycooxidative Stress on Human Aging- Study #3

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in Blood Glucose and Insulin levels in 1 year as compared to baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve insulin resistance in subjects with metabolic syndrome. Insulin resistance will be assessed by measuring simultaneously blood glucose and insulin levels in the fasting state and during an oral glucose tolerance test.

  • Change in Blood Glucose and Insulin levels in 1 year as compared to baseline [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve insulin resistance in subjects with metabolic syndrome. Insulin resistance will be assessed by measuring simultaneously blood glucose and insulin levels in the fasting state and during an oral glucose tolerance test.


Secondary Outcome Measures:
  • Change in abdominal obesity in 1 year as compared to baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve abdominal obesity and markers of cardiovascular disease in subjects with metabolic syndrome. Abdominal obesity will be measured by both waist circumference and MRI. CVD markers will be measured both in the circulation as well as by MRI estimate of carotid artery intima/media thickness.

  • Change in abdominal obesity in 1 year as compared to baseline [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve abdominal obesity and markers of cardiovascular disease in subjects with metabolic syndrome. Abdominal obesity will be measured by both waist circumference and MRI. CVD markers will be measured both in the circulation as well as by MRI estimate of carotid artery intima/media thickness.

  • Change in markers of cardiovascular disease in 1 year as compared to baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve abdominal obesity and markers of cardiovascular disease in subjects with metabolic syndrome. Abdominal obesity will be measured by both waist circumference and MRI. CVD markers will be measured both in the circulation as well as by MRI estimate of carotid artery intima/media thickness.

  • Change in markers of cardiovascular disease in 1 year as compared to baseline [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    To test whether prolonged (1 year) dietary AGE restriction, while maintaining caloric intake, can improve abdominal obesity and markers of cardiovascular disease in subjects with metabolic syndrome. Abdominal obesity will be measured by both waist circumference and MRI. CVD markers will be measured both in the circulation as well as by MRI estimate of carotid artery intima/media thickness.


Enrollment: 383
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regular AGE Diet
Regular AGE Diet
Other: Regular AGE Diet
Regular AGE Diet
Active Comparator: Low AGE Diet
One year reduction in dietary AGE intake
Other: Low AGE Diet
One year reduction in dietary AGE intake.

Detailed Description:

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 Glycation End products (AGEs) can induce oxidant stress and inflammatory responses and modulate insulin signaling in animal models and more recently in humans. These studies separated the effects of "over-nutrition" from the pro-inflammatory effects of AGEs, a factor not previously considered. These data support our hypothesis that AGE-restriction could be an important intervention in the MetSyn in aging.

The investigators would like to demonstrate that this safe, practical and economical intervention can arrest the progression of three major "epidemics" of aging: diabetes, obesity, and vascular disease associated with the metabolic syndrome. This simple intervention could have significant health and economic implications.

Our hypothesis is that dietary AGE restriction can reverse several cardinal manifestation of the MetSyn, specifically insulin resistance, abdominal obesity and cardiovascular disease.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363141

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Helen Vlassara, MD Mount Sinai School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01363141     History of Changes
Other Study ID Numbers: GCO 03-0116-3, 2RO1DK091231-07A2
Study First Received: May 27, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Cardiovascular Diseases
Type 2 Diabetes Mellitus
Abdominal Fat
Atherogenic Dyslipidemia
Hypertension
Hyperglycemia
Insulin Resistance
Thrombosis state

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014