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NCT03872375 · ClinicalTrials.gov registry record · NA
Calorie Restriction and Brain Function in Mild Cognitive Impairment
A NA study, sponsored by Iowa State University.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT03872375 is a NA study that has completed, run by Iowa State University. The registered enrollment target is 96 participants.
The verdict
NCT03872375, a NA study, has completed, sponsored by Iowa State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
Problems with blood sugar metabolism (i.e., metabolic dysfunction) progressively develop through old age, which is primarily due to obesity and lack of physical activity. Metabolic dysfunction increases the risk for Alzheimer's disease (AD) and negatively impacts memory and related brain function. There is intense interest in developing interventions, particularly non-drug therapies, to combat AD. Recent clinical trials have found that intranasal insulin, which facilitates glucose metabolism in the brain, is able to maintain memory in participants with Mild Cognitive Impairment (MCI), the precursor to AD. While intranasal insulin is a useful, proof-of-concept intervention, it does not affect visceral fat mass and therefore metabolic dysfunction will persist in a given person. The investigators wish to engage participants with MCI in intermittent calorie restriction (CR), to reduce metabolic dysfunction and improve glucose metabolism. Intermittent calorie restriction in this case refers to eating whatever one wants for 5 days, followed by 2 consecutive days of consuming 530 calories via one protein shake with sufficient nutrients to sustain the person. This results in reliable weight loss, which itself improves glucose metabolism in the body and has a wealth of other benefits. (It should be mentioned here that weight maintenance has been shown in studies when participants restrict to 1 day/week).
Interventions
- BEHAVIORAL Dietary Counseling
- DIETARY_SUPPLEMENT Meal-Replacement Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03872375
The ClinicalTrials.gov registry entry for NCT03872375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iowa State University, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dietary Counseling is the first listed.
NCT03872375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03872375 about?
NCT03872375 is a clinical study titled "Calorie Restriction and Brain Function in Mild Cognitive Impairment". Problems with blood sugar metabolism (i.e., metabolic dysfunction) progressively develop through old age, which is primarily due to obesity and lack of physical activity. Metabolic dysfunction increases the risk for Alzheimer's disease (AD) and negatively impacts memory and related brain function. T...
What is the current status of trial NCT03872375?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2019-05-08. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03872375?
The interventions under investigation include: Dietary Counseling (BEHAVIORAL), Meal-Replacement Therapy (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03872375?
This trial is sponsored by Iowa State University, which has 23 total clinical trials registered on ClinicalTrials.gov.
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