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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Institute on Aging (NIA) | NIH |
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The purpose of this pilot study is to determine whether it is feasible to conduct a randomized, controlled dietary intervention trial of high versus low dietary intake of advanced glycation end products (AGEs) in 24 adults; and to gather preliminary data on the impact of high versus low AGE diet health parameters. The investigators hypothesize that it will be feasible to conduct a randomized, parallel arm, controlled dietary intervention in a pilot study involving 24 subjects.
Advanced glycation end products (AGEs), bioactive molecules formed by the non-enzymatic glycation of proteins, are emerging as a possible dietary risk factor for many key adverse health outcomes related to obesity and to aging. Major sources of systemic AGEs are endogenous AGEs generated in the body and exogenous AGEs found in foods. When food is heated to high temperatures, the characteristic "browning" generates Maillard reaction products, known as AGEs. Although AGEs have been implicated in atherosclerosis, insulin resistance, diabetes, cardiovascular disease, aging-related eye disease, Alzheimer's disease, and chronic kidney disease, the possible adverse effects of dietary AGEs have not been well characterized in humans.
The objective of the study is to determine whether it is feasible to conduct a randomized, parallel arm, controlled dietary intervention in a pilot study involving 24 subjects; and to compare the effects of a high-AGE and low-AGE diet on (a) serum and urine carboxymethyl-lysine and serum receptor for AGEs (RAGE), (b) endothelial function, (c) interleukin-6, C-reactive protein, (d) lipids, (e) adipokines, (f) glucose metabolism and insulin resistance, (g) renal function, and (h) cognition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-AGE Diet | Experimental | The high-AGE diet will be approximately four times higher in AGEs than the low-AGE diet. |
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| Low-AGE Diet | Experimental | The low-AGE diet will be approximately four times lower in AGEs than the high-AGE diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary | Other | The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Endothelial function will be measured using peripheral arterial tonometry. | At baseline and following 6-week intervention |
| Biomarkers | Fasting venous blood samples will be drawn for measurements of CML, IL-6, CRP, leptin, adiponectin, cystatin C, cholesterol, triglycerides, glucose, insulin, sRAGE, and esRAGE. Urinary creatinine and CML also will be measured. | At baseline and following 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function and mood | Five cognitive tests and a test of mood will be used to assess various cognitive parameters including attention, memory, and reasoning. | At baseline and following 6-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Semba, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24744309 | Derived | Semba RD, Gebauer SK, Baer DJ, Sun K, Turner R, Silber HA, Talegawkar S, Ferrucci L, Novotny JA. Dietary intake of advanced glycation end products did not affect endothelial function and inflammation in healthy adults in a randomized controlled trial. J Nutr. 2014 Jul;144(7):1037-42. doi: 10.3945/jn.113.189480. Epub 2014 Apr 17. |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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