Berberine Supplementation, Sprint Interval Training, and Immune Function Study

NCT07480018 | Completed

• 1 other identifier: 2510073554
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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; Monocyte Function; Inflammation Biomarkers

Keywords

Berberine; Sprint Interval Training; Mental Health; Wellbeing; Anaerobic Power; Inflammation; Monocytes; Stressed Adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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

  Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 3 hours.

• Interleukin-6 (IL-6)

  Visit 1A (Week 0) and Visit 2A (Week 2): 15 minutes for blood draw. The assay itself takes 3 hours.

• Anaerobic Power

  Visit 1B (Week 0) and Visit 2B (Week 2): 15 minutes each.

• Depression Anxiety and Stress Scales (DASS-21)

  Visit 1A (Week 0) and 2A (Week 2): 10 minutes each

Other Outcomes (8)

• Lean Body Mass

  Visit 1A (Week 0) and Visit 2A (Week 2): 20 minutes each

• Body Fat Percentage

  Visit 1A (Week 0) and Visit 2A (Week 2): 20 minutes each

• Psychological Wellbeing Scale (PWB)

  Visit 1B (Week 0) and Visit 2B (Week 2): 6 minutes each

Study Arms (4)

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.

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.

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.

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.

Other: Placebo; Other: Sprint Interval Training

Interventions

Berberine DIETARY_SUPPLEMENT

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.

Also known as: Berberine Hydrochloride

Berberine Only Group (BO); Sprint Interval Training + Berberine Group (SB)

Placebo OTHER

Consumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals.

Placebo Only Group (PO); Sprint Interval Training + Placebo Group (SP)

Sprint Interval Training OTHER

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.

Also known as: SIT

Sprint Interval Training + Berberine Group (SB); Sprint Interval Training + Placebo Group (SP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and Females
• Aged 18-45
• DASS-21 subscale scores indicating "Mild" or greater category for Depression ≥ 10, Anxiety ≥ 7, and Stress ≥ 11

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Northern Colorado: lead

Study Sites (1)

University of Northern Colorado

Greeley, Colorado, 80631, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Inflammation

Interventions

Berberine; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators and Participants are aware of randomized exercise allocation, due to the nature of performing exercise, but masked to supplement intervention. Randomization for both training and supplement groupings will be made using a random number generator function on Excel by an individual that is not directly affiliated with data collection.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel, randomized design

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: January 1, 2026
• Primary Completion: May 3, 2026
• Study Completion: June 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: March 15, 2026 - March 15, 2029
• Access Criteria: Individuals will email Laura.stewart@unco.edu with a request for study materials.

Locations

US (1)