The Role of Brain Lactate Metabolism in Neuroprotection During Healthy Aging
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNorthern Arizona University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Need for daily medication for chronic conditions, diagnosed heart, lung, metabolic or cerebrovascular disease, smokers, pregnancy and women in perimenopause are exclusion criteria; these will be verified with questionnaires and preliminary screening.
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Sodium lactate infusion
Biological/VaccineSodium lactate will be infused to target circulating concentrations between 4-6 mmol/L
Exercise-induced hyperlactatemia
Other interventionCycling will be performed at an intensity to increase circulating lactate to 4-6 mmol/L
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Passive lactateActive comparator 1 intervention
Group B: Active lactateExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
-Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from interventionSecondary outcomes
1
Brain-specific biomarkers
Brain-derived neurotrophic factor, secreted amyloid-b precursor protein and platelet factor-4 will be quantified from concentrations measured in blood entering and exiting the brain via sampling from arterial and internal jugular venous blood.
Time frame
-Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from intervention2
Cognitive function
Several domains of cognitive function will be assessed using NIH ToolBox V3.
Time frame
-Pre-intervention in rested state -During intervention when lactate is experimentally elevated -After recovery from interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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