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

Completed · Not applicable

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT01402973

Run by

United States Department of Agriculture (USDA)

People needed

24

Starts

2011-10-01

Expected to finish

2011-11-01

Last updated by the study team

2011-11-23

Who can join

Age: 50 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• USDA Beltsville Human Nutrition Research Center — Beltsville, Maryland, United States

Full record on ClinicalTrials.gov

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