MoodPhase 1/2NCT05318456
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
A Phase 1/2 study testing MoodElite T-4003-1 and Comparator in people with Mood, run by Chenland Nutritionals Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood
- What is being tested?
- MoodElite T-4003-1 and Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2022to 20 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
Show all 15Show fewer
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- 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
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- History of diagnosed chronic or major depression as assessed by the QI
- Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI
- Suicidal ideation as assessed by the BDI-II
- History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI
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- Diagnosed insomnia or other sleep disorders as assessed by the QI
- Current employment that calls for shift work or have worked shift work in the last 3 weeks
- Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel
- Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep
- Current use of prescribed medications that interact with Hypericum perforatum
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Use of medical cannabinoid products
- Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis
- Alcohol intake >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate 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
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.
Read the 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.
- Conditions
- Mood
- Being tested
- MoodElite T-4003-1, Comparator, Placebo
- Keywords
- Mild to moderate depression, Mild to moderate depressive symptoms not eligible for therapeutic intervention, MoodElite T-4003-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodElite T-4003-1Dietary 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.
ComparatorDietary supplement
Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days.
PlaceboOther
Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: MoodElite T-4003-1 |
| 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. Receives: Dietary Supplement: Comparator |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: Days 0, 42 and day 56 (follow-up)
Secondary outcomes (13)
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Days 0 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start24 Mar 2022
- Primary completion19 Jan 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chenland Nutritionals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318456
- Sponsor's protocol ID
- 21CNCFT01
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate 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
- ClinicalTrials.gov ID
- NCT05318456
- Acronym / sponsor ID
- 21CNCFT01
- Conditions
- Mood
- Keywords
- Mild to moderate depression, Mild to moderate depressive symptoms not eligible for therapeutic intervention, MoodElite T-4003-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chenland Nutritionals Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MoodElite T-4003-1 | Experimental | Dietary Supplement: MoodElite T-4003-1Participants 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 | Dietary Supplement: ComparatorParticipants 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 | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (24 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- History of diagnosed chronic or major depression as assessed by the QI
- Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI
- Suicidal ideation as assessed by the BDI-II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoodElite T-4003-1Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food for 42 days. | Dietary supplement | MoodElite T-4003-1 |
| ComparatorParticipants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days. | Dietary supplement | Comparator |
| PlaceboParticipants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days. | Other | Placebo |
Primary outcome
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
Time frame: Days 0, 42 and day 56 (follow-up)
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.
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
Time frame: Days 0, 42 and day 56 (follow-up)
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'.
13 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 0 and 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MoodElite T-4003-1 and Comparator in people with Mood, run by Chenland Nutritionals Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Days 0, 42 and day 56 (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.