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

NCT05318456 | Completed Phase 1

• 1 other identifier: 21CNCFT01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood

Keywords

Mild to moderate depression; Mild to moderate depressive symptoms not eligible for therapeutic intervention; MoodElite T-4003-1

Outcome Measures

Primary Outcomes (2)

• 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)

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

  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

  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

  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

  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

  Days 0, 42 and day 56 (follow-up)

Other Outcomes (29)

• Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo

  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

  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

  Days 0 and 42

Study Arms (3)

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.

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.

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.

Other: Placebo

Interventions

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.

MoodElite T-4003-1

Comparator DIETARY_SUPPLEMENT

Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days.

Comparator

Placebo OTHER

Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chenland Nutritionals Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A5R8, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: March 24, 2022
• Primary Completion: January 19, 2023
• Study Completion: March 20, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

CA (1)