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

May 27, 2011
April 8, 2014
December 2010
December 2014   (final data collection date for primary outcome measure)
  • 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.
  • Change in Blood Glucose and Insulin levels [ 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 [ 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.
Complete list of historical versions of study NCT01363141 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in abdominal obesity [ 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 MRY estimate of carotid artery intima/media thickness.
  • Change in abdominal obesity [ 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 MRY estimate of carotid artery intima/media thickness.
  • Change in markers of cardiovascular disease [ 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 MRY estimate of carotid artery intima/media thickness.
  • Change in markers of cardiovascular disease [ 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 MRY estimate of carotid artery intima/media thickness.
Not Provided
Not Provided
 
Effect of a Low Advanced Glycation End Products (AGE) Diet in the Metabolic Syndrome
Effects of Glycooxidative Stress on Human Aging- Study #3

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
  • Other: Regular AGE Diet
    Regular AGE Diet
  • Other: Low AGE Diet
    One year reduction in dietary AGE intake.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
383
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01363141
GCO 03-0116-3, 2RO1DK091231-07A2
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Helen Vlassara, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
April 2014

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