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Ketones for Healthy Subjects

Phase 4
Waitlist Available
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within two weeks of enrollment completion
Awards & highlights

Study Summary

This trial is looking at the effect of insulin resistance on the brain and whether using ketones as an alternate energy source can help counteract any negative effects. There are three different arms to the study, and each one uses different methods to test different aspects of this.

Eligible Conditions
  • Healthy Subjects
  • Insulin Resistance
  • Diet Modification
  • Aging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within two weeks of enrollment completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within two weeks of enrollment completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diet related changes in brain network stability will be assessed by fMRI BOLD measurements.
Glucose uptake will be measured by PET, with and without ketone supplement
Neurotransmitter production with and without ketone supplement will be measured by magnetic resonance spectroscopy
Secondary outcome measures
Cognitive performance will be assessed by CNS Vital Signs.
Cognitive performance will be assessed by Mini Mental State Exam (MMSE).
Insulin resistance will be assessed by HbA1C.
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: Metabolic Manipulation via Ketone Supplement MR/PETExperimental Treatment2 Interventions
All subjects are tested twice, both times in a fasting condition (8 hours no food, unrestricted water). For both sessions, the investigators will intravenously administer the FDG radioisotope continuously throughout the scan. Thus, PET will map glucose uptake across the brain, while MRS is simultaneously used to measure production of the neurotransmitters glutamine and GABA. While having their brains scanned with MR/PET, subjects are initially tested at rest, and then perform a task. Subjects will drink a ketone sports drink dosed at 395mg/kg. During the glycolytic (glucose burning) session the same subjects will drink a bolus of glucose, calorie-matched to the ketones.
Group II: Arm 2: Metabolic Manipulation via Ketone Supplement fMRIExperimental Treatment2 Interventions
All subjects are tested twice, both times in a fasting condition (8 hours no food, unrestricted water). While having their brains scanned with MRI, subjects are initially tested at rest, and then perform a task. Midway through the session, subjects are removed from the scanner and drink either of two fuel sources. In the ketotic (ketone burning) session they will drink a ketone sports drink dosed at 395mg/kg. During the glycolytic (glucose burning) session the same subjects will drink a bolus of glucose, calorie-matched to the ketones. Data analyses quantify network reorganization in response to changing energy constraints (i.e., cognitive demand, fuel).
Group III: Arm 1: Metabolic Manipulation via Diet fMRIExperimental Treatment1 Intervention
All subjects are tested three times, each in a different diet-induced metabolic state: glycolytic (glucose burning), fasting (8 hours no food), and ketotic (fat burning). While having their brains scanned with MRI, subjects are initially tested at rest, and then perform a task. Midway through the session, subjects are removed from the scanner and drink up to 75g glucose. Data analyses quantify network reorganization in response to changing energy constraints (i.e., cognitive demand, fuel).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dextrose, unspecified form
FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
217 Previous Clinical Trials
39,906 Total Patients Enrolled
Martinos Center for Biomedical ImagingOTHER
7 Previous Clinical Trials
340 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dynamic Connectivity Under Metabolic Constraints
2015. "Dynamic Connectivity Under Metabolic Constraints". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04106882.
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