- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791837
Brain Blood Flow and Lactate in Non-obese and Obese Subjects
Cerebral Lactate Uptake and Transport in Obese and Non-Obese Individuals
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.
Study Overview
Detailed Description
Blood lactate is often considered a waste product from aerobic metabolism. Many people assume it causes fatigue and muscle. Lactate is a signaling molecule in the body. In addition lactate is also a fuel. Evidence supports that lactate may be more important when the brain is stressed. We also know that individuals with obesity and/or type 2 diabetes may have impaired lactate metabolism.
The investigators will compare brain blood flow and lactate response to an exercise stress test and submaximal exercise in obese and non-obese individuals.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matt McDonald, MS
- Phone Number: 6185815501
- Email: mjmdr4@missouri.edu
Study Contact Backup
- Name: Jill Kanaley, PhD
- Phone Number: 5738822519
- Email: kanaleyj@missouri.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- Recruiting
- University of Missouri
-
Contact:
- Jill Kanaley, PhD
- Phone Number: 5738822519
- Email: kanaleyj@missouri.edu
-
Contact:
- Matt McDonald, MS
- Phone Number: 618-581-5501
- Email: mjmdr4@missouri.edu
-
Principal Investigator:
- Jill Kanaley, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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).
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non-obese
individuals with a BMI<25 kg/m2
|
each group will undergo a max test and a submaximal exercise test
|
|
obese
individuals with a BMI 30-40 kg/m2
|
each group will undergo a max test and a submaximal exercise test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
brain blood flow
Time Frame: over the 30 minutes of testing
|
Using transcranial doppler we will measure brain blood flow
|
over the 30 minutes of testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lactate concentrations
Time Frame: over ~ 60 minutes of testing
|
Lactate will be measured in response to an exercise stress test as well as to a submaximal exercise bout
|
over ~ 60 minutes of testing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill Kanaley, PhD, University of Missouri-Columbia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Overweight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 2125746
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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