NCT01402973

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

July 25, 2011

Last Update Submit

November 22, 2011

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Cognitive function and mood

    At baseline and following 6-week intervention

Study Arms (2)

High-AGE Diet

EXPERIMENTAL

The high-AGE diet will be approximately four times higher in AGEs than the low-AGE diet.

Other: Dietary

Low-AGE Diet

EXPERIMENTAL

The low-AGE diet will be approximately four times lower in AGEs than the high-AGE diet.

Other: Dietary

Interventions

DietaryOTHER

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

High-AGE DietLow-AGE Diet

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • 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.

    PMID: 24744309DERIVED

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Richard Semba, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

US(1)