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

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01402973
First received: July 25, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Healthy Adults
Other: Dietary

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: At baseline and following 6-week intervention ] [ Designated as safety issue: No ]
    Endothelial function will be measured using peripheral arterial tonometry.

  • Biomarkers [ Time Frame: At baseline and following 6-week intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cognitive function and mood [ Time Frame: At baseline and following 6-week intervention ] [ Designated as safety issue: No ]
    Five cognitive tests and a test of mood will be used to assess various cognitive parameters including attention, memory, and reasoning.


Estimated Enrollment: 24
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-AGE Diet
The high-AGE diet will be approximately four times higher in AGEs than the low-AGE diet.
Other: Dietary
The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs.
Experimental: Low-AGE Diet
The low-AGE diet will be approximately four times lower in AGEs than the high-AGE diet.
Other: Dietary
The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 years or older and less than 70 years of age
  • Non-smoker
  • Body mass index of 18.5 to <30 mg/kg2

Exclusion Criteria:

  • Diabetes, thyroid disease, angina, myocardial infarction, heart failure, stroke, peripheral artery disease, chronic obstructive pulmonary disease, inflammatory bowel disease, liver disease, chronic kidney disease, or Raynaud's disease
  • Taking regular vitamin supplements, or if taking regular vitamin supplements, not willing to discontinue taking vitamin supplements while participating in the study
  • Taking vitamin B6 (pyridoxamine) supplements (50 mg or more)
  • Taking aspirin or nonsteroidal anti-inflammatory medications (NSAIDS), or if so, not willing to discontinue taking aspirin or NSAIDS while participating in the study
  • Major food allergies (i.e., dairy, nuts, etc)
  • History of eating disorders or other dietary patterns that are not consistent with the dietary intervention (e.g. vegetarians, very low fat diets, high protein diets)
  • Loss of 10% of body weight within the last 12 months or plan to initiate a weight loss program during the next two months
  • Self-report of alcohol or substance abuse with the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the study doctor may interfere with study participation or the ability to follow the intervention protocol
  • Not willing to consume the diets being tested by the study
  • Cognitive impairment, indicated by a Mini-Mental State Exam score <23
  • Triglycerides >300 mg/dL
  • Hemoglobin ≤11 g/dL
  • Creatinine greater or equal to 1.5 mg/dL
  • Fasting plasma glucose >125 mg/dL
  • Proteinuria
  • Long fingernails on the index finger of each hand, or if so, not willing to trim these two fingernails so that peripheral arterial tonometry can be conducted during the study
  • Not willing to give written, informed consent to participate in the study
  • Women who are lactating or pregnant, or plan to become pregnant during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402973

Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Johns Hopkins University
Investigators
Principal Investigator: Richard Semba, MD, MPH The Johns Hopkins University School of Medicine
  More Information

No publications provided

Responsible Party: Richard Semba, The Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT01402973     History of Changes
Other Study ID Numbers: AGE Dietary Intervention
Study First Received: July 25, 2011
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on April 17, 2014