The purpose of this clinical trial is to investigate the effects of a 2-week intervention involving berberine supplementation or sprint training in isolation as well as berberine combined with sprint training on well-being, anaerobic power, and monocyte number and function in individuals experiencing mild mental health challenges. The main questions it aims to answer are: * Does short-term berberine use or sprint training improve measures of mental health, psychological wellbeing, fatigue, and sleep quality? * Does short-term berberine use or sprint training improve measures of anaerobic power generation? * Does short-term berberine use or sprint training improve circulating biomarkers of inflammation? * Does short-term berberine use or sprint training improve monocyte number, function, and cytokine production?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
Consumption of a commercially-available Berberine supplement at a dosage of 500mg, Three times per day with meals, for a total dosage of 1500mg/day.
Consumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals.
Multiple sets of maximal effort 30 second sprints, inter spaced with 4 minutes of rest/active recovery, on the cycle ergometer over the course of 6 sessions during the 2-Week intervention. Resistance for each set is calculated at 7.5% of the body mass of the participant. Sets for each session are as follows: (1) 4 Sets, (2) 5 Sets, (3) 6 Sets, (4) 6 Sets, (5) 7 Sets, (6) 4 Sets.
University of Northern Colorado
Greeley, Colorado, United States
RECRUITINGMonocyte Number
Whole blood single cell suspension, 200 μL, will be stained for CD14 (anti-human CD14-FITC) and CD16 (anti-human CD16-APC) (BioLegend, San Diego CA) following lysis of red blood cells with 1X Red Blood Cell Lysis Buffer (BioLegend, San Diego CA) and blocking of Fc receptors with Fc-Blocker (BioLegend, San Diego CA). Prepared samples will be run on an Attune NxT flow cytometer (Thermo Fisher Scientific, Waltham, MA) following fixation and permeabilization.
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.
Monocyte Production of Intracellular IL-6
100 µL of cells will be aliquoted into 12 x 75 mm tubes alongside 150 μL of Cyto-Fast™ Fix/Perm Solution (BioLegend, San Diego CA), then incubated for 20 minutes at room temperature. Then, 1 mL of 1X Cyto-Fast™ Perm Wash Solution (BioLegend, San Diego CA) will be added, then centrifuged at 350xg for 5 minutes and the supernatant discarded, repeated twice. Cells will then be stained with optimal concentrations of PE anti-human IL-6 antibody (BioLegend, San Diego CA) prepared as a master mix of 100 μL with 1X Cyto-Fast™ Perm Wash, then incubated for 20 minutes at room temperature in the dark. Then, the cells will be washed with 1 mL of 1X Cyto-Fast™ Perm Wash, then centrifuged at 350xg for 5 minutes. Discard supernatant, add 1 mL of Cell Staining Buffer (BioLegend, San Diego CA), then centrifuge at 350xg for 5 minutes. Discard supernatant, resuspend cells in 600 uL of Cell Staining Buffer (BioLegend, San Diego CA) and run on Attune NxT (Thermo Fisher Scientific, Waltham, MA).
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.
C-Reactive Protein
Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of CRP will be determined with a commercially available enzyme-linked immunosorbent assay (ALPCO Diagnostics, Salem, NH, USA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 3 hours.
Interleukin-6 (IL-6)
Approximately 60mL of whole blood will be collected into serum separator tubes (Beckton Dickinson, East Rutherford, NJ, USA), allowed to clot for 30-min at room temperature, then centrifuged at 2000 RPM for 15 min. The serum will be pipetted into 1.5 mL microcentrifuge tubes (Eppendorf AG, Hamburg, Germany) and immediately stored in a -80 °C freezer. Serum concentrations of IL-6 will be determined with a commercially available enzyme-linked immunosorbent assay (BioLegend, San Diego CA). Microplates will be read with an ELx800 BioTek microplate reader (BioTek Instruments, Inc., Winooski, VT, USA) at the recommended wavelength of 450 nanometers.
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 3 hours.
Anaerobic Power
Participants will complete a measure of anaerobic fitness using the Wingate anaerobic power test on a cycle ergometer (Monark Ergomedic 894E, Monark, Varberg, Sweden). Participants will warm-up between 60-75 revolutions per minute (RPM) at a self-selected resistance for 5 minutes. Upon completion of the warm-up, resistance will be dropped to 0, and the participant will then be instructed to begin pedaling at their max cadence. Once participants reach their max pedal cadence, 7.5% of the participant's body mass will be added to the cycle ergometer, and the test will begin. Participants will cycle for a total of 30 seconds at a resistance of 7.5% body mass. At the cessation of the 30 second max test, participants will cycle for an additional 5 minutes at a self-selected resistance for their cool-down. Measurements of peak anaerobic power, mean anaerobic power, relative peak anaerobic power, total work, fatigue index, and heart rate max will be recorded.
Time frame: Visit 1B (Week 0) and Visit 2B (Week 2): 15 minutes each.
Depression Anxiety and Stress Scales (DASS-21)
Participants will be asked to complete a paper version of the 21-item Depression Anxiety and Stress Scale (DASS-21). The DASS-21 consists of 21 questions using a 0-3 Likert scale assessing the participant's subjective mental health and stress state with a "0" indicating "Did not apply to me at all" and "3" indicating "Applied to me very much or most of the time." The DASS-21 contains 3 sub scales assessing Depression, Anxiety, and Stress consisting of 7 questions for each sub scale, where a high score of 28+ indicates "Extremely Severe" levels of Depression, a high score of 20+ indicates "Extremely Severe" levels of Anxiety, and a high score of 34+ indicates "Extremely Severe" levels of Stress, while low scores of 0-9 indicates "Normal" levels of Depression, scores of 0-7 indicates "Normal" levels of Anxiety, and scores of 0-14 indicates "Normal" levels of Stress.
Time frame: Visit 1A (Week 0) and 2A (Week 2): 10 minutes each
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