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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: Completed NA study, sponsored by Iowa State University.
NCT03872375 is a NA study that has completed, run by Iowa State University. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
% change in BMI (kg/m2)
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 |
What the finished NCT03872375 record still lists
NCT03872375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Dietary Counseling is the first listed.
NCT03872375 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03872375's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 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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