Clinical trial NCT06406946: Mushrooms, Mood and Mental Wellbeing in Gen Z Women
Official title: Investigating the Effects of Lions Mane Mushroom, and a Mushroom Blend on Wellbeing in Stressed/Anxious Gen Z Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Mood
Anxiety
Stress
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will follow a randomized, double-blind, placebo-controlled, parallel group design. Participants will receive either lion's mane, a blend of lion's mane mushroom and reishi mushroom or placebo to be consumed at home each day.

Participants will initially attend a virtual screening session (conducted via telephone call or Microsoft Teams), this session will involve:obtaining of informed consent, health screening, completion of the Caffeine Consumption Questionnaire (CCQ) and collection of demographic information. Participants will then attend testing labs on two occasions.

The first session will take place at an agreed time, with no restrictions to the participant in terms of abstinence from caffeine, food etc - participants will be encouraged to follow their normal routine and to also do this prior to completing the other assessments. This session will comprise collection of physiological measures that cannot be completed remotely (blood pressure, height and weight,waist-hip-ratio). Participants will then complete the baseline wellbeing questionnaires: 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). Participants will receive their treatment, they will be instructed to consume 3 capsules per day for the next 28-days. This appointment will take \~30 mins.

At home on Days 7, 14 and 21 participants will complete interim mood questionnaires. During these they will complete the HADS and S-VAS only.

On Day 28, participants will return to the laboratory to complete their final wellbeing assessment in person. This is the full wellbeing assessment as completed on Day 1. During this visit participants will also return their unused treatment and complete a treatment guess form. Participants will also provide qualitative (written) feedback on if they felt any changes in their mood/wellbeing during the course of the trial.

To assess if there are any wellbeing changes following ceasing consumption of treatment, participants will also complete a final wellbeing assessment on Day 42 (14 days after treatment ending). For this assessment they will complete the GAD-7, HADS and SVAS, alongside the qualitative feedback on any observed changes since stopping the treatment.

A sample of 135 women aged 18-26 (born between 1997-2013) who feel that they are anxious and/or stressed (but with no diagnosis of a psychiatric disorder) will be recruited from the North East area to take part in this study. Participants will be randomly allocated to one of the active treatments, or placebo, neither the participant nor the researcher will know which group they have been allocated to.

Eligibility 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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline, following 28 days supplementation and 14 days after ceasing supplementation
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline, following, 7, 14, 21 and 28 days supplementation and 14 days after ceasing supplementation
measure: Stress
timeFrame: Baseline and following 28 days supplementation
measure: Stress
timeFrame: Baseline, following, 7, 14, 21 and 28 days supplementation and 14 days after ceasing supplementation
measure: Fatigue
timeFrame: Baseline and following 28 days supplementation
measure: Self Esteem
timeFrame: Baseline and following 28 days supplementation
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre, Northumbria University
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Sarah Docherty, PhD
role: PRINCIPAL_INVESTIGATOR
References: