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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: Completed NA study, sponsored by National Institute on Aging (NIA).
NCT04421014 is a NA study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 99 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
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. ...
Primary Outcome
β-hydroxybutyrate (BHB) was quantified in the posteromedial cortex (PMC) using ¹H-MRS (PRESS). Acute and acute-on-chronic responses were defined as the within-visit ratios of \~75 minutes post-drink to pre-drink (post/pre) at Weeks 0 and 4, respectively. The chronic effect was defined as the ratio of pre-drink BHB at Week 4 to pre-drink at Week 0 (Week 4 pre / Week 0 pre). BHB values were derived from spectral fitting with predefined quality-control criteria.
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 |
What the finished NCT04421014 record still lists
NCT04421014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 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 Ketone Ester drink is the first listed.
NCT04421014 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04421014's enrollment target sits among peer trials
99 920th of 2000 higher than 1,079 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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