RecruitingNot ApplicableNCT06406946

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

Investigating the Effects of Lions Mane Mushroom, and a Mushroom Blend on Wellbeing in Stressed/Anxious Gen Z Women

Sponsor

Northumbria University

Enrollment

135 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Stress Anxiety Well-Being, Psychological Mood

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 26 Years

Inclusion Criteria4

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 Criteria14

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