NCT06791837

Brief Summary

Cerebral blood flow (CBF) is essential for maintaining brain health and function, as it ensures delivery oxygen and nutrients necessary to support neuronal activity. Reduced CBF can impair the brain's ability to meet its metabolic demands, leading to deficits in cognitive ability. Impairments in CBF are associated with cognitive decline and neurodegenerative disease such as Alzheimer's and dementia. Many factors influence CBF, but recently lactate has emerged as a key player. Blood glucose has long been considered the primary fuel for the brain, but emerging evidence indicates that lactate may be the preferred fuel for neurons, and lactate may become even more important under stressful conditions. Individuals with obesity often have impaired lactate metabolism resulting in higher resting blood lactate concentrations and reduced ability to clear lactate after a physiological stress. At the same time, it is known that exercise is a powerful intervention for improving lactate metabolism. Thus, this project seeks to investigate the role of lactate in brain blood flow in individuals with and without obesity as well as establish if short term exercise training (individuals with obesity only) will alter circulating lactate concentrations at rest and in response to exercise.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
May 2025Mar 2027

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

January 19, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

lactateobesityexercise

Outcome Measures

Primary Outcomes (1)

  • brain blood flow

    Using transcranial doppler we will measure brain blood flow

    over the 30 minutes of testing

Secondary Outcomes (1)

  • lactate concentrations

    over ~ 60 minutes of testing

Study Arms (2)

non-obese

individuals with a BMI\<25 kg/m2

Behavioral: EXERCISE

obese

individuals with a BMI 30-40 kg/m2

Behavioral: EXERCISE

Interventions

EXERCISEBEHAVIORAL

each group will undergo a max test and a submaximal exercise test

non-obeseobese

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals that live in the area of Columbia, MO

You may qualify if:

  • healthy adult men and women 18-45 years of age BMI 18-40 kg/m2 not pregnant, premenopausal with regular menstrual cycles not breastfeeding non-nicotine users

You may not qualify if:

  • medications known to affect sleep, autonomic control, blood lactate levels or metabolic, or cardiovascular function (PI discretion) self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse major cardiovascular event or surgical procedure within the past three months hypertension (\>140/90 mmHg or at PIs discretion).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

Related Publications (3)

  • Xue X, Liu B, Hu J, Bian X, Lou S. The potential mechanisms of lactate in mediating exercise-enhanced cognitive function: a dual role as an energy supply substrate and a signaling molecule. Nutr Metab (Lond). 2022 Jul 30;19(1):52. doi: 10.1186/s12986-022-00687-z.

    PMID: 35907984BACKGROUND
  • Bouzier-Sore AK, Voisin P, Canioni P, Magistretti PJ, Pellerin L. Lactate is a preferential oxidative energy substrate over glucose for neurons in culture. J Cereb Blood Flow Metab. 2003 Nov;23(11):1298-306. doi: 10.1097/01.WCB.0000091761.61714.25.

    PMID: 14600437BACKGROUND
  • Brooks GA, Osmond AD, Arevalo JA, Duong JJ, Curl CC, Moreno-Santillan DD, Leija RG. Lactate as a myokine and exerkine: drivers and signals of physiology and metabolism. J Appl Physiol (1985). 2023 Mar 1;134(3):529-548. doi: 10.1152/japplphysiol.00497.2022. Epub 2023 Jan 12.

    PMID: 36633863BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jill Kanaley, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt McDonald, MS

CONTACT

Jill Kanaley, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

only coded IPD will be shared that is used in the results published

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 1 year after publication and ending 5 yr after publication of results
Access Criteria
Mean data will be shared for meta analysis For access to individual data, a proposal that described the planned analysis must be submitted and an agree must be signed by the applicant. These documents would be submitted to the PI.
More information

Locations