NCT07731451

Brief Summary

The brain's primary source of fuel is glucose. Unfortunately, the brain's ability to use glucose declines during normal aging. This decline in brain glucose metabolism makes it vulnerable to cognitive impairment and Alzheimer's disease. The brain can use another fuel source - lactate - which becomes available to the brain during exercise. The investigators have discovered that when lactate fuels the brain, brain glucose metabolism also improves. Essentially, from a metabolic angle, the brain appears younger. Recently, the investigators have shown that lactate - even in the absence of exercise - stimulates this beneficial effect on the brain. The investigators propose to compare the effects of lactate in healthy young and older adults to test whether these beneficial lactate-mediated effects persist throughout the lifespan, thereby providing a blueprint to restore youthful brain glucose metabolism.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
24mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 16, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

brain metabolismlactateexerciseaging

Outcome Measures

Primary Outcomes (1)

  • Cerebral metabolism

    Lactate, glucose and oxygen metabolism via stable isotope tracers and Fick method using arterial and internal jugular venous blood sampling in combination with cerebral blood flow via ultrasound. These will be quantified as rates in grams/minute or mililiters/minute.

    -Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from intervention

Secondary Outcomes (2)

  • Brain-specific biomarkers

    -Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from intervention

  • Cognitive function

    -Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from intervention

Study Arms (2)

Passive lactate

ACTIVE COMPARATOR

Circulating lactate will be elevated via infusion

Biological: Sodium lactate infusion

Active lactate

EXPERIMENTAL

Circulating lactate will be elevated via exercise

Other: Exercise-induced hyperlactatemia

Interventions

Sodium lactate will be infused to target circulating concentrations between 4-6 mmol/L

Passive lactate

Cycling will be performed at an intensity to increase circulating lactate to 4-6 mmol/L

Active lactate

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the American College of Sports Medicine (ACSM) physical activity guidelines for moderate-intensity aerobic activity, i.e., 150+ minutes of moderate or 75+ minutes of rigorous aerobic activity.
  • The older cohort must have adhered to these physical activity guidelines for 30+ years.
  • "Good" or "Excellent" aerobic fitness category based on ACSM standardized maximal aerobic power (V̇O2max) values for age and sex.

You may not qualify if:

  • Significant carotid plaque will be excluded via ultrasound assessment.
  • Evidence of mild cognitive impairment (MCI)
  • Personal complaints of memory deficits, clinical diagnosis, or evidence from the NIH ToolBox ®V3 will be considered signs of MCI.
  • known allergy to Lidocaine also cannot participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University Dept of Biological Sciences

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

TRAVIS GIBBONS, PhD

CONTACT

Tinna Traustadottir, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Repeated measures cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 28, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

To maintain privacy and confidentiality of participants.

Locations