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Brain Substrate Switch for Metabolic Diseases and Age-Related Issues (BSS Trial)
N/A
Waitlist Available
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collected at rest, during graded infusions of lactate and ketones, pre- and post- 6 minutes of high-intensity cycling exercise
Awards & highlights
BSS Trial Summary
This trial will investigate if switching brain fuel sources during fasting and exercise benefits the brain. Healthy participants will fast/exercise and receive infusions to isolate the brain's metabolic flexibility. Brain biomarkers BDNF and sAPPA will be measured.
Who is the study for?
This trial is for young, healthy individuals who are regularly physically active. It's not suitable for smokers, those on daily prescription meds that affect exercise response, women with menstrual irregularities or who are pregnant/post-menopausal, obese individuals (BMI over 30), or anyone with diseases that complicate exercise.Check my eligibility
What is being tested?
The study tests how the brain switches from using glucose to ketones and lactate during fasting and high-intensity cycling. Participants will fast for three days and perform intense exercise; they'll also receive infusions of ketones and lactate to mimic these states without actual fasting or exercising.See study design
What are the potential side effects?
Potential side effects may include discomfort from fasting such as headaches or dizziness, muscle soreness from high-intensity cycling, and possible reactions at the infusion site like redness or swelling.
BSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ data collected at rest, during graded infusions of lactate and ketones, pre- and post- 6 minutes of high-intensity cycling exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected at rest, during graded infusions of lactate and ketones, pre- and post- 6 minutes of high-intensity cycling exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain-derived neurotrophic factor, secreted amyloid beta precursor protein
Secondary outcome measures
Brain substrate metabolism
BSS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FastedExperimental Treatment1 Intervention
Exercise and passive infusions of ketones and lactate in the fasted state. Participants will be required to fast for 72 hours prior to arriving to the lab for this testing arm.
Group II: FedActive Control1 Intervention
Exercise and passive infusions of ketones and lactate in the fed state. Participants will be fed a small meal in the middle of the protocol, also.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,422 Previous Clinical Trials
2,468,248 Total Patients Enrolled
1 Trials studying Metabolic Diseases
23 Patients Enrolled for Metabolic Diseases
University of OtagoOTHER
36 Previous Clinical Trials
39,932 Total Patients Enrolled
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