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

NCT01363141 | Completed DMC

• 2 other identifiers: GCO 03-0116-32R01DK091231-07A2
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Blood Glucose and Insulin levels in 1 year as compared to 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.

  baseline

• Change in Blood Glucose and Insulin levels in 1 year as compared to 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.

  after 1 year

Secondary Outcomes (4)

• Change in abdominal obesity in 1 year as compared to baseline

  baseline

• Change in abdominal obesity in 1 year as compared to baseline

  after 1 year

• Change in markers of cardiovascular disease in 1 year as compared to baseline

  baseline

• Change in markers of cardiovascular disease in 1 year as compared to baseline

  after 1 year

Study Arms (2)

Regular AGE Diet

ACTIVE COMPARATOR

Regular AGE Diet

Other: Regular AGE Diet

Low AGE Diet

ACTIVE COMPARATOR

One year reduction in dietary AGE intake

Other: Low AGE Diet

Interventions

Regular AGE Diet OTHER

Regular AGE Diet

Regular AGE Diet

Low AGE Diet OTHER

One year reduction in dietary AGE intake.

Low AGE Diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (8)

• Uribarri J, Woodruff S, Goodman S, Cai W, Chen X, Pyzik R, Yong A, Striker GE, Vlassara H. Advanced glycation end products in foods and a practical guide to their reduction in the diet. J Am Diet Assoc. 2010 Jun;110(6):911-16.e12. doi: 10.1016/j.jada.2010.03.018.

  PMID: 20497781 BACKGROUND

• Mericq V, Piccardo C, Cai W, Chen X, Zhu L, Striker GE, Vlassara H, Uribarri J. Maternally transmitted and food-derived glycotoxins: a factor preconditioning the young to diabetes? Diabetes Care. 2010 Oct;33(10):2232-7. doi: 10.2337/dc10-1058. Epub 2010 Jul 13.

  PMID: 20628088 BACKGROUND

• Uribarri J, Cai W, Ramdas M, Goodman S, Pyzik R, Chen X, Zhu L, Striker GE, Vlassara H. Restriction of advanced glycation end products improves insulin resistance in human type 2 diabetes: potential role of AGER1 and SIRT1. Diabetes Care. 2011 Jul;34(7):1610-6. doi: 10.2337/dc11-0091.

  PMID: 21709297 BACKGROUND

• Vlassara H, Striker GE. Advanced glycation endproducts in diabetes and diabetic complications. Endocrinol Metab Clin North Am. 2013 Dec;42(4):697-719. doi: 10.1016/j.ecl.2013.07.005.

  PMID: 24286947 BACKGROUND

• Striker GE. Beyond phosphate binding: the effect of binder therapy on novel biomarkers may have clinical implications for the management of chronic kidney disease patients. Kidney Int Suppl. 2009 Dec;(114):S1-2. doi: 10.1038/ki.2009.400. No abstract available.

  PMID: 19946321 BACKGROUND

• 6. Vlassara, H. and Striker, G.E. (2010) Intake of advanced glycation endproducts; Role in the development of diabetic complications. In: Principles of Diabetes Mellitus, 2nd Edition, L. Poretsky, Ed., Springer Publications.

  BACKGROUND

• 7. Vlassara, H, Striker, G.E. The Role of AGEs in the Etiology of Insulin Resistance and Diabetes; US-Endocrinology (2011).

  BACKGROUND

• Vlassara H, Cai W, Tripp E, Pyzik R, Yee K, Goldberg L, Tansman L, Chen X, Mani V, Fayad ZA, Nadkarni GN, Striker GE, He JC, Uribarri J. Oral AGE restriction ameliorates insulin resistance in obese individuals with the metabolic syndrome: a randomised controlled trial. Diabetologia. 2016 Oct;59(10):2181-92. doi: 10.1007/s00125-016-4053-x. Epub 2016 Jul 29.

  PMID: 27468708 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypertension; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases

Study Officials

• John C He, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)