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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363141
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date May 8, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • Change in Blood Glucose and Insulin levels in 1 year as compared to baseline [ Time Frame: baseline ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Change in Blood Glucose and Insulin levels [ Time Frame: baseline ]
    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 [ Time Frame: after 1 year ]
    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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • Change in abdominal obesity in 1 year as compared to baseline [ Time Frame: baseline ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Change in abdominal obesity [ Time Frame: baseline ]
    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 MRY estimate of carotid artery intima/media thickness.
  • Change in abdominal obesity [ Time Frame: after 1 year ]
    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 MRY estimate of carotid artery intima/media thickness.
  • Change in markers of cardiovascular disease [ Time Frame: baseline ]
    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 MRY estimate of carotid artery intima/media thickness.
  • Change in markers of cardiovascular disease [ Time Frame: after 1 year ]
    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 MRY estimate of carotid artery intima/media thickness.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Low Advanced Glycation End Products (AGE) Diet in the Metabolic Syndrome
Official Title  ICMJE Effects of Glycooxidative Stress on Human Aging- Study #3
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Other: Regular AGE Diet
    Regular AGE Diet
  • Other: Low AGE Diet
    One year reduction in dietary AGE intake.
Study Arms  ICMJE
  • Active Comparator: Regular AGE Diet
    Regular AGE Diet
    Intervention: Other: Regular AGE Diet
  • Active Comparator: Low AGE Diet
    One year reduction in dietary AGE intake
    Intervention: Other: Low AGE Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2013)
383
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
120
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363141
Other Study ID Numbers  ICMJE GCO 03-0116-3
2R01DK091231-07A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: John C He, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP