Effects of 2-Weeks of Berberine and Sprint Interval Training on Wellbeing, Anaerobic Power, and Monocyte Number and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Monocyte Number
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •Aged 18-45
- •DASS-21 subscale scores indicating "Mild" or greater category for Depression ≥ 10, Anxiety ≥ 7, and Stress ≥ 11
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Other)
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.
干预措施: Sprint Interval Training (Other)
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.
干预措施: Placebo (Other)
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.
干预措施: Sprint Interval Training (Other)
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.
干预措施: Berberine (Dietary Supplement)
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.
干预措施: Berberine (Dietary Supplement)
结局指标
主要结局
Monocyte Number
时间窗: 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
时间窗: 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).
次要结局
- 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)
研究者
Laura Stewart
Professor
University of Northern Colorado