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The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.
Age
45 - 65 years
Sex
ALL
Healthy Volunteers
No
Population Health Center Clinic George Mason University
Fairfax, Virginia, United States
Start Date
August 25, 2022
Primary Completion Date
December 14, 2023
Completion Date
December 14, 2023
Last Updated
May 8, 2024
30
ACTUAL participants
Individualized Nutrition Therapy
OTHER
Lead Sponsor
George Mason University
NCT05119179
NCT06909773
NCT06505109
Data Source & Attribution
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