Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metabolic Syndrome
  • Normal Cognition
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Basic Science

Participation Requirements

Age
Between 55 years and 125 years
Gender
Both males and females

Description

We hypothesize that supplementation with a ketone ester drink [HVMN Ketone Ester (KE)] compared to placebo, in cognitively intact adults 55 years old with Metabolic Syndrome (Mets), will (i) increase peripheral and brain ketone levels [primarily f3-hydroxybutyrate (BHB) and secondarily acetoacetate ...

We hypothesize that supplementation with a ketone ester drink [HVMN Ketone Ester (KE)] compared to placebo, in cognitively intact adults 55 years old with Metabolic Syndrome (Mets), will (i) increase peripheral and brain ketone levels [primarily f3-hydroxybutyrate (BHB) and secondarily acetoacetate (AcAc)], (ii) improve neuronal/astrocytic insulin resistance (IR) and induce a change in neuronal/astrocytic metabolism as reflected on blood Extracellular Vesicle (EV) biomarkers, (iii) improve cognitive performance, (iv) boost mitochondrial function in muscle, and (v) change gut microbiome. These effects will be examined acutely, after single (NotEqual) dose administration, and chronically, after 28 days on the supplement x 3 times per day. The changes in EV biomarkers and cognition will be associated with the elevation of ketones in brain. The study will involve a Screening Visit and three additional Visits to assess acute effects, compliance and chronic effects, respectively.

Tracking Information

NCT #
NCT04421014
Collaborators
Not Provided
Investigators
Principal Investigator: Dimitrios I Kapogiannis, M.D. National Institute on Aging (NIA)
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