The Safety and Efficacy of AlphaWave® L-Theanine on Adults Who Experience Moderate Stress on a Regular Basis

NCT05808595 | Completed Phase 2

• 1 other identifier: 22ENCLR01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of AlphaWave® L-Theanine on stress among adults who experience moderate stress on a regular basis. The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 will be compared between AlphaWave® L-Theanine and Placebo groups. Additionally, the safety and tolerability of AlphaWave® L-Theanine, as compared to placebo, will be measured by the occurrence of an/or changes in pre-emergent and post-emergent adverse events (AEs).

Conditions

Stress

Keywords

Safety and efficacy; Stress

Outcome Measures

Primary Outcomes (1)

• The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

Secondary Outcomes (31)

• The difference in change in stress as measured by the Perceived Stress Scale (PSS) from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

• The difference in change in the stress subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

• The difference in change in the depression subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

• The difference in change in the anxiety subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

• The difference in change in the total score measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo.

  Day 0, day 14, day 28

Study Arms (2)

AlphaWave® L-Theanine

EXPERIMENTAL

Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily.

Dietary Supplement: AlphaWave® L-Theanine

Placebo

PLACEBO COMPARATOR

Participants will be instructed to take one capsule twice daily, once in the morning and once in the evening with water with or without food, starting on Day 1. If a dose is missed participants are instructed to take the missed dose immediately once noticed unless it is noticed within two hours of taking their next dose in which case, participants are instructed to document the missed dose and continue with their regular dosing schedule. Participants will be advised not to exceed 3 capsules daily.

Other: Placebo

Interventions

AlphaWave® L-Theanine DIETARY_SUPPLEMENT

One capsule of AlphaWave® L-Theanine will be taken twice daily for 28 days.

AlphaWave® L-Theanine

Placebo OTHER

One capsule of Placebo will be taken twice daily for 28 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 65 years of age, inclusive
• Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
• Females 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:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), 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 moderate stress as determined by a score of 14 - 26 on the Perceived Stress Scale
• Agrees to maintain current sleep schedule throughout study
• Must have a high school diploma or equivalent and basic computer skills
• Agrees to avoid high caffeine consumption (examples include but not limited to no more than 2 cups/day of caffeinated coffee or tea)
• Agrees to refrain from vigorous physical activity 24-hr prior to study visits
• Agrees to maintain current lifestyle as much as possible including current sleep schedule until the end of the study
• Willingness to complete questionnaires, records and diaries associated with the study, and to complete all clinic visits

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Participants who have a known allergy to the Investigational Product (IP) or Placebo active or inactive ingredients
• Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
• Travelled across 1 or more time zones in the 3 weeks prior to run-in and/or is anticipating more travel
• Self-reported diagnosis with a stress or sleep disorder as assessed by the QI
• Self-reported diagnosis of a neuropsychiatric and/or cognitive impairment as assessed by the QI
• Self reported colour-blindness
• Type I or Type II Diabetes
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant disease of the gastrointestinal tract 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
• Significant cardiovascular event in the past 6 months as assessed by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. 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

Sponsors & Collaborators

• Ethical Naturals, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

Location

Related Publications (1)

• Moulin M, Crowley DC, Xiong L, Guthrie N, Lewis ED. Safety and Efficacy of AlphaWave(R) L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial. Neurol Ther. 2024 Aug;13(4):1135-1153. doi: 10.1007/s40120-024-00624-7. Epub 2024 May 17.

  PMID: 38758503 DERIVED

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 11, 2023
• Study Start: April 4, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: May 8, 2024

Record last verified: 2023-09

Locations

CA (1)