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NCT03117829 · ClinicalTrials.gov registry record · NA
Study: Diet and Exercise Study to Improve Brain Blood Flow: Blood Flow Improvement Trial
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03117829: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT03117829 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03117829, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Project Summary Metabolic syndrome (MetS) is associated with the development of diabetes and cardiovascular disease; however it is also linked with cognitive decline and dementia. The study investigators have shown that MetS is associated with lower cerebral blood flow (CBF) and memory function in late middle-aged adults at increased risk for developing Alzheimer's disease (AD). Insulin resistance (IR) is at the core of MetS, and a hallmark feature of IR is higher fasting blood glucose (FBG) as well as post prandial hyperglycemia. While the study investigators and others have demonstrated links between IR and CBF as well as cognition from an observational perspective, no studies have investigated CBF and cognition after an intervention involving exercise and a carbohydrate restricted diet (CRD) designed to improve or normalize IR and glucose homeostasis. The study investigators propose to determine the effect of improving or normalizing glucose homeostasis on CBF and cognition, through diet and exercise, in individuals with IR and at risk for the development of AD. While exercise and a CRD have been shown to improve IR and glycemic control, we have only limited knowledge of the mechanisms behind these improvements. Nutritional metabolomics, the global measurement and interpretation of metabolic profiles, assesses the interaction of diet with the endogenous gene-protein cascade and the gut microbiome. Additionally, exercise has been shown to have an impact on the human metabolome. Finally, numerous metabolites have been specifically linked to IR and impaired fasting glucose (IFG). The study investigators propose to use metabolomics to measure changes in metabolites as individuals normalize or improve IR and glucose homeostasis. Should this exploratory study reveal increased brain blood flow and improved memory in response to diet and exercise, then early treatment of these individuals at risk might offer new avenues for disease-course modification. Strategies towa
Primary Outcome
Change in brain blood flow from baseline to 12 weeks
Interventions
- BEHAVIORAL Diet and Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2019-06-17 |
| Phase | NA |
What the finished NCT03117829 record still lists
NCT03117829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Diet and Exercise is the first listed.
NCT03117829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03117829 about?
NCT03117829 is a clinical study titled "Study: Diet and Exercise Study to Improve Brain Blood Flow: Blood Flow Improvement Trial". Project Summary Metabolic syndrome (MetS) is associated with the development of diabetes and cardiovascular disease; however it is also linked with cognitive decline and dementia. The study investigators have shown that MetS is associated with lower cerebral blood flow (CBF) and memory function in l...
What is the current status of trial NCT03117829?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2017-03-15. Estimated completion is 2019-06-17.
What interventions are being tested in trial NCT03117829?
The interventions under investigation include: Diet and Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT03117829?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03117829's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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