The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention
Condition: Mood
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1
      on improving mood in a healthy adult population with mild to moderate depressive symptoms not
      eligible for therapeutic intervention.
    

Detailed description: 
      The objective of this study is to investigate the safety and efficacy of 42-day
      supplementation of MoodElite T-4003-1 on improving mood in healthy adults. The efficacy of
      MoodElite T-4003-1 on mood will be assessed by the Beck Depression Inventory (BDI-II) and
      Profile of Mood States (POMS) Questionnaire. POMS is a self-reported assessment of mood that
      is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect
      states and contributes to a comprehensive assessment by providing indications of potential
      mood disturbance. Self-reported sleep efficiency, perceived sleep debt, and sleep difficulty
      will be assessed by a Sleep Quality Questionnaire and supported by sleep scoring from
      actigraphy readings. As vitality is related to both mood and sleep, the Vitality and Quality
      of Life questionnaire will be used to measure changes in energy levels and quality of life
      over the 42-day study period. The effects of MoodElite T-4003-1 will be compared to a placebo
      and comparator product, EasyMind T-4008-1. EasyMind T-4008-1 contains extracts from Paeonia
      lactiflora, Gardenia jasminoides, Albizia julibrissin, Paeonia suffruticosa and has been
      shown to reduce anxiety-like behaviour in a rodent model using chronic restraint stress
      through reduction of corticosterone (cortisol) (unpublished results).

      For the study population, the eligibility criteria limits the presence of confounding
      variables that could influence study outcomes. Participants will be healthy men and women
      between 18 and 65 years of age. Individuals will be recruited based on having mild to
      moderate depressive symptoms, as assessed by the BDI-II. The BDI-II contains 21 items and
      evaluates both psychological and physical symptoms related to depression. Participants with
      diagnosed chronic or major depression or psychiatric disorders will be excluded to ensure
      only those with mild, non-pathological depressive symptoms are enrolled. Any participants
      taking prescribed or over the counter mood altering medications will be excluded, as not to
      interfere with the evaluation of the effects of MoodElite T-4003-1 on mood. Participants
      taking supplements for mood support at a stable dose for at least three months will be
      evaluated by the QI to determine eligibility. Shift workers or individuals who have recently
      travelled across one or more time zones will be excluded to limit any confounding effects on
      outcomes.
    

Intervention name(s): MoodElite T-4003-1; Comparator; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food for 42 days.; Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days.; Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to moderate depression; Mild to moderate depressive symptoms not eligible for therapeutic intervention; MoodElite T-4003-1