BerberineNCT07480018
Berberine Supplementation, Sprint Interval Training, and Immune Function Study
A study testing Berberine and Sprint Interval Training in people with Berberine and Sprint Training, run by University of Northern Colorado at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Berberine, Sprint Training, Wellbeing
- What is being tested?
- Berberine and Sprint Interval Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and Females
- Aged 18-45
- DASS-21 subscale scores indicating "Mild" or greater category for Depression ≥ 10, Anxiety ≥ 7, and Stress ≥ 11
Who cannot join
- Regular berberine intake in the last 2 months
- Performs SIT regularly in the last month
- Pregnant or planning to become pregnant
- Chronic use of anti-inflammatory medication or medications that affect liver metabolism
- Prior history of chronic conditions such as Cardiovascular Disease, Diabetes, and Cancer
- Severe and untreated anxiety or depression
- Severe Peanut Allergies
- Any contraindications to performing high intensity exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Northern Colorado
Greeley, Colorado, 80631
About this study
Official title: Effects of 2-Weeks of Berberine and Sprint Interval Training on Wellbeing, Anaerobic Power, and Monocyte Number and Function
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?
- Conditions
- Berberine, Sprint Training, Wellbeing, Anaerobic Power, Inflammation Biomarkers, Monocyte Function
- Being tested
- Berberine, Placebo, Sprint Interval Training
- Keywords
- Berberine, Sprint Interval Training, Mental Health, Wellbeing, Anaerobic Power, Inflammation, Monocytes, Stressed Adults
- Medical subject headings
- Psychological Well-Being, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDietary supplement
Also called Berberine Hydrochloride
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.
PlaceboOther
Consumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals.
Sprint Interval TrainingOther
Also called SIT
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.
| Study group | Role | What they receive |
|---|---|---|
| Berberine Only Group (BO) | Active comparator | Participants in BO will consume a commercially-available Berberine supplement (500mg, 3x Daily with Meals) for 2-weeks stored in identical vegan capsules and instructed to maintain daily activities and diets. Receives: Dietary Supplement: Berberine |
| Placebo Only Group (PO) | Placebo comparator | Participants in PO will consume placebo capsules (rice flour, 3x Daily with Meals) stored in identical vegan capsules for 2-weeks and instructed to maintain daily activities and diets. Receives: Other: Placebo |
| Sprint Interval Training + Berberine Group (SB) | Active comparator | Participants in SB will consume a commercially-available Berberine supplement (500mg, 3x Daily with Meals) stored in identical vegan capsules and will undergo 6 Sprint Interval Training sessions for 2-weeks. Receives: Dietary Supplement: Berberine; Other: Sprint Interval Training |
| Sprint Interval Training + Placebo Group (SP) | Placebo comparator | Participants in SP will consume placebo capsules (rice flour, 3x Daily with Meals) stored in an identical vegan capsules and will undergo 6 Sprint Interval Training sessions for 2-weeks. Receives: Other: Placebo; Other: Sprint Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte 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.
Measured: 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).
Measured: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1A (Week 0) and 2A (Week 2): 10 minutes each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jan 2026
- Primary completion3 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BerberineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, randomized design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480018
- Sponsor's protocol ID
- 2510073554
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study documents will be made available upon reasonable request (Laura.stewart@unco.edu).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2-Weeks of Berberine and Sprint Interval Training on Wellbeing, Anaerobic Power, and Monocyte Number and Function
- ClinicalTrials.gov ID
- NCT07480018
- Acronym / sponsor ID
- 2510073554
- Conditions
- Berberine, Sprint Training, Wellbeing, Anaerobic Power, Inflammation Biomarkers, Monocyte Function
- Keywords
- Berberine, Sprint Interval Training, Mental Health, Wellbeing, Anaerobic Power, Inflammation, Monocytes, Stressed Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 3 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel, randomized design
| Arm | Type | Receives |
|---|---|---|
| Berberine Only Group (BO) | Active comparator | Dietary Supplement: BerberineParticipants in BO will consume a commercially-available Berberine supplement (500mg, 3x Daily with Meals) for 2-weeks stored in identical vegan capsules and instructed to maintain daily activities and diets. |
| Placebo Only Group (PO) | Placebo comparator | Other: PlaceboParticipants in PO will consume placebo capsules (rice flour, 3x Daily with Meals) stored in identical vegan capsules for 2-weeks and instructed to maintain daily activities and diets. |
| Sprint Interval Training + Berberine Group (SB) | Active comparator | Dietary Supplement: Berberine, Other: Sprint Interval TrainingParticipants in SB will consume a commercially-available Berberine supplement (500mg, 3x Daily with Meals) stored in identical vegan capsules and will undergo 6 Sprint Interval Training sessions for 2-weeks. |
| Sprint Interval Training + Placebo Group (SP) | Placebo comparator | Other: Placebo, Other: Sprint Interval TrainingParticipants in SP will consume placebo capsules (rice flour, 3x Daily with Meals) stored in an identical vegan capsules and will undergo 6 Sprint Interval Training sessions for 2-weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and Females
- Aged 18-45
- DASS-21 subscale scores indicating "Mild" or greater category for Depression ≥ 10, Anxiety ≥ 7, and Stress ≥ 11
Key exclusion criteria (8 listed)
- Regular berberine intake in the last 2 months
- Performs SIT regularly in the last month
- Pregnant or planning to become pregnant
- Chronic use of anti-inflammatory medication or medications that affect liver metabolism
- Prior history of chronic conditions such as Cardiovascular Disease, Diabetes, and Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerberineAlso: Berberine HydrochlorideConsumption of a commercially-available Berberine supplement at a dosage of 500mg, Three times per day with meals, for a total dosage of 1500mg/day. | Dietary supplement | Berberine Only Group (BO), Sprint Interval Training + Berberine Group (SB) |
| PlaceboConsumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals. | Other | Placebo Only Group (PO), Sprint Interval Training + Placebo Group (SP) |
| Sprint Interval TrainingAlso: SITMultiple 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. | Other | Sprint Interval Training + Berberine Group (SB), Sprint Interval Training + Placebo Group (SP) |
Primary outcome
Monocyte Number
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.
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.
Monocyte Production of Intracellular IL-6
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.
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).
4 secondary outcomes
C-Reactive Protein
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)
Time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 3 hours.
Anaerobic Power
Time frame: Visit 1B (Week 0) and Visit 2B (Week 2): 15 minutes each.
Depression Anxiety and Stress Scales (DASS-21)
Time frame: Visit 1A (Week 0) and 2A (Week 2): 10 minutes each
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. All study documents will be made available upon reasonable request (Laura.stewart@unco.edu).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine and Sprint Interval Training in people with Berberine and Sprint Training, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte Number (time frame: Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 8 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.