NCT01402973

Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: United States Department of Agriculture (USDA) · Federal
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
OTHER	Dietary	The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs.

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-07-26
• Last updated: 2011-11-23

Locations

1 site across 1 country: United States