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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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anxiety-like behaviour in a rodent model using chronic restraint stress through reduction of corticosterone (cortisol) (unpublished results).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MoodElite T-4003-1 | Experimental | Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily. |
|
| Comparator | Active Comparator | Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily. |
|
| Placebo | Placebo Comparator | Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoodElite T-4003-1 | Dietary Supplement | Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food for 42 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by BDI-ll | The change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Beck Depression Inventory-II (BDI-II). The BDI-II contains 21 items on a 4-point scale from 0 'Symptom Absent' to 3 'Severe Symptom'. Scoring is achieved by adding the highest ratings for all 21 items with a minimum score of 0 and maximum score of 63. A higher total BDI-II score indicates greater symptom severity. | Days 0, 42 and day 56 (follow-up) |
| Change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS Questionnaire | The change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
Inclusion Criteria:
Individuals 18-65 years of age, inclusive
Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening
Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI)
Education level no less than that of primary school
Individuals who can read and write in English and can understand the BDI-II
Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history and laboratory results as assessed by QI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A5R8 | Canada |
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| Comparator | Dietary Supplement | Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days. |
|
| Placebo | Other | Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days. |
|
| Days 0, 42 and day 56 (follow-up) |
| Change in depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Change in anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Change in vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Change in fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Change in confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS | The change in POMS subscale of confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are 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. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'. | Days 0, 42 and day 56 (follow-up) |
| Change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire | The change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'. | Days 0 and 42 |
| Change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire | The change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'. | Days 0 and 42 |
| Change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire. | The change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'. | Days 0 and 42 |
| Change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by actigraphy readings | The change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using actigraphy readings. The actigraphy device is an objective measure of sleep during the study period. Each subject will wear the actigraphy device on their non-dominant arm for seven consecutive days prior to each study visit, allowing for charging and periods when the device is may not be worn (i.e. showering). The actigraphy device will be used to collect sleep outcome variables including but not limited to sleep start and end, average length and number of awakenings, sleep efficiency, sleep latency, time asleep, wake episodes, and fragmentation index. | Days 0 and 42 |
| Change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by Vitality and Quality of Life Questionnaire | The change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Vitality and Quality of Life Questionnaire. The Vitality and QoL Questionnaire will be used to assess the energy levels and quality of life of the participants. The 31-item questionnaire consists of a 7-point Likert scale, with answers ranging from 1 to 7. The higher the summative score the more vitality that was subjectively perceived by the participants. | Days 0 and 42 |
| Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation | The change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured. | Days 0 and 42 |
| Change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation | The change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured. | Days 0 and 42 |
| Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo |
Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. |
| Days 0 and 42 |
| Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo | Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined. | Days 0 and 42 |
| Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo | Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined. | Days 0 and 42 |
| Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |
| Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo | Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined. | Days 0 and 42 |