Comparison of Pharmacokinetic Responses to Three Ketone Esters

NCT07289165 | Active Not Recruiting

• 1 other identifier: NE-01-2025
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. This study is considered investigational because data are being collected on the differences over time between three active study products. Consumption of these study products are not intended to diagnose, treat, cure, or prevent any disease.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

• Serum BHB concentration maximum (Cmax)

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• time to maximum concentration (Tmax)

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• area under the curve (AUC),

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• elimination half-life (T1/2),

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• oral clearance

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• volume of distribution

  blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

Secondary Outcomes (2)

• Visual Analogue Scale for GI tolerance

  assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

• Safety (vital signs) and Adverse Events

  assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product

Study Arms (3)

12.5mg Ketone Tri Ester

ACTIVE COMPARATOR

Dietary Supplement containing Tri-betahydroxybutyrin

Dietary Supplement: Dietary Supplement containing Tri-betahydroxybutyrin

12.5mg Ketone Mono Ester

ACTIVE COMPARATOR

Dietary Supplement containing a ketone mono Ester

Dietary Supplement: Dietary Supplement containing a ketone mono Ester

12.5mg Ketone Salt

ACTIVE COMPARATOR

Dietary supplement containing a ketone salt

Dietary Supplement: Dietary supplement containing a ketone salt

Interventions

Dietary Supplement containing Tri-betahydroxybutyrin DIETARY_SUPPLEMENT

Ketone Tri Ester

12.5mg Ketone Tri Ester

Dietary Supplement containing a ketone mono Ester DIETARY_SUPPLEMENT

Ketone Mono Ester

12.5mg Ketone Mono Ester

Dietary supplement containing a ketone salt DIETARY_SUPPLEMENT

Dietary Supplement from a ketone salt

12.5mg Ketone Salt

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• Age between 30 and 70 yr (inclusive).
• Body Mass Index of 25-34.9 (inclusive).
• Body weight of at least 120 pounds.
• Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal seated, resting heart rate (\<90 per minute).
• Willing to duplicate and record their previous 24-hour diet, refrain from caffeine, alcohol and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
• Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
• Subject is willing and able to comply with the study protocol.

You may not qualify if:

• Individuals using any kind of GLP-1 medications.
• Individuals who are determined to have liver, renal, cardiovascular, neurological, or other metabolic disease.
• History or presence of diabetes, prediabetes or endocrine disorder.
• Use of any dietary supplements or medications which may confound the study or its endpoints (e.g., fish oil, choline donors, gingko biloba, phosphatidylserine, huperzine A, etc.).
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
• Current nicotine use \> 100 mg/day.
• History of hyperparathyroidism or an untreated thyroid condition.
• History of malignancy in the previous 5 years, except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• History of chronic psychiatric conditions (e.g., bipolar, schizophrenia, PTSD, depression, etc.).
• History of brain disorders \[e.g., stroke, MS, Parkinson's, history of TBI or epilepsy, migraine (\>1 migraine per month), etc.\].
• Prior gastrointestinal bypass surgery (Lapband), etc.
• Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Inflammatory bowel syndrome (IBS), Inflammatory bowel disease (IBD; e.g., Crohn's, ulcerative colitis), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition (e.g., rheumatoid arthritis, Lupus, HIV/AIDS, etc.).
• Previous medical diagnosis of asthma, gout, or fibromyalgia.
• Currently following a low-carbohydrate, keto type diet, or practicing an intermittent fasting lifestyle (\>14 hours of fasting).

Sponsors & Collaborators

• NeuroEnergy Ventures, Inc.: lead

Study Sites (1)

CAHS

Canfield, Ohio, 44406, United States

Location

Study Officials

• Tim Ziegenfuss, PhD

  CAHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 17, 2025
• Study Start: July 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)