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NCT04421014 · ClinicalTrials.gov registry record · NA
Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults 55 Years Old or Older
A NA study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT04421014 is a NA study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 99 participants.
The verdict
NCT04421014, a NA study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study Summary
Background: In Alzheimer s disease (AD) the brain cannot use glucose as a fuel. The brain can use ketones as a fuel instead of glucose. Researchers want to test a supplement, Ketone Ester (KE). It may improve brain metabolic function and cognition in normal people and, perhaps, down the road, in patients with AD. Objective: To study the change in brain ketone levels in people after 28 days of taking KE compared with baseline and placebo. Also, to study changes in cognitive performance. Eligibility: People 55 years old or older with metabolic syndrome and no cognitive impairment Design: Participants will have 4 visits. Participants will be screened at Visit 1 with: Medical history Physical exam Blood and urine tests Cognitive testing Participants will be randomly assigned to receive either the study supplement or a placebo with same amount of calories. Neither they nor the researchers will know which they receive. Visit 2 will include repeats of some screening tests. It will also include: Stool sample (brought from home) MRI/MRS: Participants will lie on a table that slides in and out of a scanner. A coil will be placed over their head. They may be asked to perform leg exercises. First dose of study supplement or placebo About 2 weeks after Visit 2, Visit 3 will include blood and urine tests and a questionnaire. About 2 weeks after Visit 3, Visit 4 will include repeats of the Visit 2 tests. Participants will drink the study supplement or placebo 3 times per day during the study. They will keep a daily log of each dose. They will bring the log to Visits 3 and 4. Participants will by contacted by phone once per week during the study to see how they are doing. ...
Interventions
- DIETARY_SUPPLEMENT Ketone Ester drink
- DIETARY_SUPPLEMENT Placebo: isocaloric dextrose drink
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2025-06-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421014
The ClinicalTrials.gov registry entry for NCT04421014 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketone Ester drink is the first listed.
NCT04421014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04421014 about?
NCT04421014 is a clinical study titled "Ketone Ester Effects on Biomarkers of Brain Metabolism and Cognitive Performance in Cognitively Intact Adults 55 Years Old or Older". Background: In Alzheimer s disease (AD) the brain cannot use glucose as a fuel. The brain can use ketones as a fuel instead of glucose. Researchers want to test a supplement, Ketone Ester (KE). It may improve brain metabolic function and cognition in normal people and, perhaps, down the road, in pa...
What is the current status of trial NCT04421014?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2021-06-24. Estimated completion is 2025-06-02.
What interventions are being tested in trial NCT04421014?
The interventions under investigation include: Ketone Ester drink (DIETARY_SUPPLEMENT), Placebo: isocaloric dextrose drink (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04421014?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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