Status:
COMPLETED
Pilot Study of a Dietary Intervention Based Upon Advanced Glycation End Products
Lead Sponsor:
United States Department of Agriculture (USDA)
Collaborating Sponsors:
Johns Hopkins University
National Institute on Aging (NIA)
Conditions:
Healthy Adults
Eligibility:
All Genders
50-69 years
Phase:
NA
Brief 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 produc...
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 relat...
Eligibility Criteria
Inclusion
- 50 years or older and less than 70 years of age
- Non-smoker
- Body mass index of 18.5 to \<30 mg/kg2
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01402973
Start Date
October 1 2011
End Date
November 1 2011
Last Update
November 23 2011
Active Locations (1)
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1
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705