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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel, randomized design
Primary Purpose
Other
Masking
Double (Participant, Investigator)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Berberine Only Group (BO) 		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
    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.
    Other names:
    • Berberine Hydrochloride
Placebo Comparator
Placebo Only Group (PO) 		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
    Consumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals.
Active Comparator
Sprint Interval Training + Berberine Group (SB) 		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
    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.
    Other names:
    • Berberine Hydrochloride
  • Other: Sprint Interval Training
    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.
    Other names:
    • SIT
Placebo Comparator
Sprint Interval Training + Placebo Group (SP) 		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
    Consumption of placebo capsules composed of rice flour at a dosing of 3 capsules per day with meals.
  • Other: Sprint Interval Training
    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.
    Other names:
    • SIT

Recruiting Locations

University of Northern Colorado
Greeley, Colorado 80631

More Details

Status
Recruiting
Sponsor
University of Northern Colorado

Study Contact

Taylor K Tamanaha
808-227-5483
keola.tamanaha@unco.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.