Variations in Ketone Metabolism

Part of paid clinical trials in Novato, California.

Sponsor
Ohio State University
Study ID
NCT05924295
Status
Recruiting
Apply to this trial

Conditions

  • Ketosis

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ketone Supplement — DIETARY_SUPPLEMENT
    Participants will be given 360mg/kg
  • Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale — BEHAVIORAL
    Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale will be administered at beginning and end of testing day to tests palatability of supplement
  • Blood Draw — BIOLOGICAL
    IV cannula will be inserted at the start of Test Day, and removed at the end of Test Day. Blood samples will be collected at 7 timepoints (possibly 1 more). Cannula will be flushed with a small volume of saline after each sample to maintain patency.
  • Urine Analysis — OTHER
    Prior to consumption of the Study Product, participants will be asked to completely void bladder. And hydration status will be determined via urine specific gravity (USG) reporting \<1.025. Urine passed after the ingestion of the study product will be collected in a plastic container; participants will be asked to void their bladder and collect urine at the end of the test day. The volume produced will be recorded at the end of the study and aliquots will be frozen and stored for future analysis

Study Details

This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health

Key Dates

Start date
Jun 20, 2023
Status verified
May 2025
Primary completion
Nov 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: C8 Ketone Supplement
    360mg/kg of supplement will be given on a singular testing day.

Primary Outcome Measure

Capillary d-BHB [ Time Frame: 4 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Buck InstituteNovatoCalifornia94945
Brianna Stubbs, DPhil
[email protected]
415-209-2072
The Ohio State UniversityColumbusOhio43210
Jeff Volek, PhD
[email protected]
614-688-1701
Madison Kackley, PhD
[email protected]
614-247-9650

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By research site
The Buck Institute· Novato, CAThe Ohio State University· Columbus, OH

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