Effects of mushroom supplements on mood and mental wellbeing in young women
Investigating the Effects of Lions Mane Mushroom, and a Mushroom Blend on Wellbeing in Stressed/Anxious Gen Z Women
This study is testing whether taking lion's mane mushroom or a mix of lion's mane and reishi mushroom can help young women aged 18 to 26 feel less stressed and anxious over 28 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 26 Years |
| Sex | All |
| Sponsor | Northumbria University Academic / other |
| Locations | 1 site (Newcastle upon Tyne, Tyne and Wear) |
| Trial ID | NCT06406946 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a 28-day supplementation of lion's mane mushroom and a blend of lion's mane and reishi mushroom on the wellbeing of stressed or anxious women aged 18 to 26. Participants will be randomly assigned to receive either the mushroom supplements or a placebo in a double-blind manner. The study will assess various psychological measures, including anxiety and stress levels, using validated questionnaires at baseline and after the supplementation period. Participants will also attend testing labs for physiological assessments and complete some questionnaires at home during the study.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 26 who identify as stressed or anxious.
Not a fit: Patients with pre-existing medical conditions that may interfere with the study or those currently on prescription medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural supplement option for improving mood and reducing anxiety in young women.
How similar studies have performed: While there is emerging interest in the effects of mushrooms on mental health, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Identify as a woman * Are aged 18 to 26 years at the time of giving consent (to be classified as Gen Z participants must have been born 1997-2013) * Rate themselves as stressed and/or anxious * Be a native speaker of English or fluent in English Exclusion Criteria: * Have any pre-existing medical condition/illness which will impact taking part in the study. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance NOTE: the explicit exceptions to this is controlled hayfever, asthma, hypo/hyperthyroidism, high blood pressure, high cholesterol, reflux, dyslexia/dyscalculia, ADHD, autism. * Are currently taking prescription medications (NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening). Within this trial medication for diagnosed neurological conditions (e.g. ADHD) will be allowed as long as medication has been taken for a minimum of 3 months and will be taken consistently throughout the trial period. * Have relevant food allergies/ intolerances/ sensitivities * Excessive caffeine intake (\> 500 mg per day) * Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taken are out of choice and not medically prescribed or advised. NOTE - Vitamin D and iron supplements are allowed for this trial if they have been advised by GP to increase levels to a normal range and have been taken for at least 4 weeks consistently and will be taken consistently throughout the trial. * Are pregnant, seeking to become pregnant or lactating * Have taken antibiotics within the past 4 weeks * Are currently participating in other clinical or nutrition intervention studies, or have done so in the past 4 weeks * Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months * Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months (this includes medically diagnosed anxiety and depression) * Suffer from frequent migraines that require medication (more than or equal to 1 per month) * Sleep disorders or are taking sleep aid medication * Have any known active infections * Will be non-compliant with treatment consumption
Where this trial is running
Newcastle upon Tyne, Tyne and Wear
- Brain, Performance and Nutrition Research Centre, Northumbria University — Newcastle upon Tyne, Tyne and Wear, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sarah Docherty, PhD — Northumbria University
- Study coordinator: Sarah Docherty, PhD
- Email: sarah4.docherty@northumbria.ac.uk
- Phone: 0191 227 3484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.