Last reviewed · How we verify
NCT06406946
Investigating the Effects of Lions Mane Mushroom, and a Mushroom Blend on Wellbeing in Stressed/Anxious Gen Z Women
NA trial testing Lion's mane blend in Well-Being, Psychological in 135 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Northumbria University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 15 April 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 February 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Lion's mane blend
- Lion's mane and reishi blend
- Placebo
Conditions studied
- Well-Being, Psychological — all drugs for Well-Being, Psychological →
- Mood — all drugs for Mood →
- Anxiety — all drugs for Anxiety →
- Stress — all drugs for Stress →
Sponsor
Northumbria University
Who can join
Adults 18 to 26, any sex, with Well-Being, Psychological or Mood. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Anxiety
Time frame: Baseline, following 28 days supplementation and 14 days after ceasing supplementation
Ratings of anxiety measured via the Generalised Anxiety Disorder Assessment (GAD-7). The outcome of the questionnaire is reported as a score between 0 and 21, with 0 indicating no anxiety and 21 indicating the highest level of anxiety. Scores are clinically categorised as: 0-4 (none), 5-9 (mild), 10-14 (moderate) and 15-21 (severe).
Sponsor's own description
The aim of the study is to investigate the effects of 28 days supplementation of Lions mane mushroom and mushroom blend of Lions mane and reishi mushroom, on wellbeing in stressed or anxious women. The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane mushroom mane (1.8 gram per day, consisting of 3 x 600mgcapsules), a blend of lion's mane mushroom and reishi mushroom 1.8 gram per day, consisting of 3x600mg capsules) or placebo (1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules). The trial will utilise Generalised Anxiety Disorder Assessment (GAD-7); the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS); Chalder Fatigue Scale; Rosenberg's Self-Esteem Scale; Perceived Stress Scale (PSS) and Stress Visual Analogue Scales (S-VAS) at baseline and after 28 days supplementation. Participants will complete the HADS and S-VAS at home on days 7, 14 and 21. On day 42 (14 days after treatment ending) participants will complete the GAD-7, HADS and S-VAS. 135 healthy women (who self-report being stressed and/or anxious) aged 18-26 (and born between 1997 and 2013) will be recruited using opportunity sampling. Participants will be supplied with either one of the active treatments or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06406946
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Well-Being, Psychological
Currently open trials in the same condition.
- NCT07221422 — The PREGNANT (Pregnant Resident Empowerment, GuidaNce, and Advocacy iN Training) Coaching Project · NA · recruiting
- NCT07240571 — Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH) · NA · recruiting
- NCT06874790 — RCT for Latina Mental Health Using Web-Based Apps · NA · recruiting
- NCT07102017 — A Randomized Controlled Trial of Robotic Support for Enhanced Later Life (RoSELL) · NA · active not recruiting
- NCT06822777 — RISE for Nurse Preceptors · NA · active not recruiting
Other Northumbria University trials
Trials by the same sponsor.
- NCT07501611 — Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation · NA · not yet recruiting
- NCT07242430 — 12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being · NA · not yet recruiting
- NCT07235878 — 12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being · NA · not yet recruiting
- NCT07297485 — Evaluating the Level of Agreement Between Goniometer Measurements and Algorithm to Determine Wall Squat Position · completed
- NCT06967454 — Manipulation of Whey Permeate Formulation for Better Fluid Retention. · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06406946 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northumbria University
- Last refreshed: 7 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06406946.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing