BHB and Cognition During Exercise-Heat Stress

NCT07010666 | Completed

• 1 other identifier: Pro00139698
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates how consuming a ketone ester (BHB) along with caffeine impacts cognitive performance under heat stress, similar to what military personnel experience in hot environments. The extreme heat can impair brain function, affecting decision-making and performance, which is critical for Special Operations Forces (SOF). BHB provides an alternative energy source for the brain, potentially improving brain blood flow and cognition, particularly during "stressful" situations. By comparing ketone and carbohydrate intake with caffeine, this study aims to find better ways to maintain mental sharpness during stressful conditions. The results could help enhance the safety and effectiveness of military operations.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Changes in Inhibitory Control by reaction time (Go/No go)

  To determine if the intervention has an impact on inhibitory control by measuring reaction time to Go targets (hits).

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in Inhibitory Control by reaction time by errors (Go/No go)

  To determine if the intervention has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in Attention (Go/No go)

  To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in Object Hit and Avoid (OHA) task: Total accuracy, Target accuracy, and Non-target accuracy

  To determine the effects of the intervention on rapid response execution and inhibition during complex continuous task performance, changes in total accuracy, target accuracy, and non-target accuracy in response to the intervention will be assessed.

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in 1-Back Task

  The determine the effects of the intervention on working memory capacity.

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in 2-Back Task

  The determine the effects of the intervention on working memory capacity.

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Changes in Hopkins Verbal Learning Task

  The determine the effects of the intervention on verbal learning and memory

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

Secondary Outcomes (4)

• Heart Rate

  Heart rate monitors will be outfitted at baseline (at the beginning of experimental visits) and heart will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average heart rates will be recorded.

• Core Body Temperature

  rectal thermometers outfitted at baseline (at the beginning of experimental visits) and core temperature will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average temperature will be recorded.

• Blood Ketone Levels

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

• Blood Glucose Levels

  On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).

Study Arms (2)

Ketone Supplementation

EXPERIMENTAL

Participants received 25g of BHB ketone ester and 4 mg/kg of caffeine.

Dietary Supplement: Beta-Hydroxybutyrate; Dietary Supplement: Caffeine

Control

ACTIVE COMPARATOR

Participants received 25g of carbohydrate and 4 mg/kg of caffeine.

Dietary Supplement: Carbohydrate; Dietary Supplement: Caffeine

Interventions

Beta-Hydroxybutyrate DIETARY_SUPPLEMENT

25 grams of BHB

Ketone Supplementation

Carbohydrate DIETARY_SUPPLEMENT

25 grams of carbohydrate

Control

Caffeine DIETARY_SUPPLEMENT

4 mg/kg of caffeine

Control; Ketone Supplementation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male and female participants who are between 18 and 35 years of age (inclusive).
• Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
• Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
• Exercise regularly as per physical activity guidelines for Americans3 \[structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)\] and willing to maintain the same level of physical activity throughout the study period.
• Can maintain their exercise status at the beginning of the study throughout the study period.
• Can achieve a peak oxygen consumption at screening that is at least 55 ml/kg/min.
• Have normal or acceptable to the investigator vital signs (BP and HR) at screening.
• Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Female participants who are lactating, pregnant or planning to become pregnant during the study.
• Carry a diagnosis of diabetes.
• Weigh less than or equal to 80 pounds at any visits.
• Answer "yes" to any of the questions asked on the screening questionnaire.
• Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
• Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible.
• Consume more than two standard alcoholic drinks per day.
• Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study.
• Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume.
• Smoking tobacco products.
• Have a history of alcohol or substance abuse in the 12 months prior to the screening visit.
• Are cognitively impaired and/or unable to give informed consent.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
• Have a current or previous diagnosis with SARS-CoV-2 in the three months prior to screening.
• Have had major surgery three months prior to screening or have a planned major surgery during the course of the study.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Interventions

3-Hydroxybutyric Acid; Carbohydrates; Caffeine

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Ketone Bodies; Ketones; Fatty Acids, Volatile; Fatty Acids; Lipids; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Taste matched placebo
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Exercise Science Department

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 8, 2025
• Study Start: January 29, 2025
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)