Cannabidiol and Focus Study (CBD-Focus)
Condition: Healthy
Study type: Interventional

Summary: 
      Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target,
      and is most supported by the scientific community as an antiepileptic, anxiolytic, and
      antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness,
      fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus,
      sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in
      inflammatory response in the human body, which has implications in both healthy and diseased
      populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses
      and are an essential component of your immune system. In humans, NKC contain the highest
      concentrations of receptors associated with the endocannabinoid system and CBD. Human models
      have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However,
      similar models found that CBD administration inhibits markers of NKC cytotoxic function, a
      beneficial cellular mechanism used to prevent malignant cell transformation and viral
      infection. The overarching goal of this investigation is to determine the effects of an
      8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive
      function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this
      study will explore a potential CBD mechanism of action with a focus on biomarkers of neural
      health, inflammation, liver health, kidney health, as well as NKC number and function.
    

Detailed description: 
      BACKGROUND: Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive
      therapeutic target, and is most supported by the scientific community as an antiepileptic,
      anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health
      and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to
      maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with
      alterations in inflammatory response in the human body, which has implications in both
      healthy and diseased populations. In humans, natural killer cells (NKC) contain the highest
      concentrations of receptors associated with the endocannabinoid system and CBD. Human models
      have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However,
      similar models found that CBD administration inhibits markers of NKC cytotoxic function, a
      beneficial cellular mechanism used to prevent malignant cell transformation and viral
      infection. The overarching goal of this investigation is to determine the effects of an
      8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive
      function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this
      study will explore a potential CBD mechanism of action with a focus on biomarkers of neural
      health, inflammation, liver health, kidney health, as well as NKC number and function.

      METHODS: In this double-blind, placebo-controlled, 4 arm clinical trial, male and female
      participants will undergo 2 pre intervention study visits and 3 post intervention study
      visits separated by an 8-week intervention period. Participants must be aged 18-50 years old,
      currently completing at least 150 minutes of moderate to vigorous physical activity per week,
      have a body mass index under 29.9, with no significant physical or mental health (without the
      presence of chronic depression or anxiety) conditions. Subjects may not have an allergy to
      soy. All study subjects must also be free of cannabis product use or regular high doses of
      antioxidants for the previous 8 weeks. Supplementation groups will be randomly assigned into
      groups consuming one of 4 beverages: 1) a beverage with 40 mg of CBD (CBD40, n=50), 2) a
      beverage with 20 mg of CBD (CBD20, n=50), 3) a beverage with 0 mg of CBD (CBD0, n=50) or 4)
      calorie-matched placebo (PLAC, n=50).

      INTERVENTION DESCRIPTION: Participants will be instructed to consume one beverage per day
      following their last meal, 1-1.5h before bed. Four weeks of beverages will be provided at a
      time. These beverage deposits will include an in person check in at the midpoint of the
      study. Participants and researchers will be blinded to the intervention groups. All
      participants will be given a 4-week supply of beverages. Investigators will meet with
      participants weekly via zoom/phone call and to report any adverse side effects or changes in
      physical activity routine. All products will be provided by Ocean Spray. All products are
      hemp derived, within legal limits and have had their purity verified. Following the
      completion of data collection for all study participants, researchers will be unblinded to
      supplementation groups.
    

Intervention name(s): Daily Beverage Intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Individuals will consume one of 4 beverages, daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants will be randomly assigned to 1 of 4 groups and followed throughout the 8 week intervention period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Cannabidiol