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Well-Being, PsychologicalNCT06406946

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

A study testing Lion's mane blend and Lion's mane and reishi blend in people with Well-Being, Psychological and Mood, run by Northumbria University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Well-Being, Psychological, Mood, Anxiety
What is being tested?
Lion's mane blend and Lion's mane and reishi blend
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited Kingdom
Study dates
15 Apr 2024to 30 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Brain, Performance and Nutrition Research Centre, Northumbria University

    Newcastle upon Tyne, Tyne and Wear, NE1 8ST

Other trials in United Kingdom

About this study

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

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).

Read more

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.

Read the 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.

Being tested
Lion's mane blend, Lion's mane and reishi blend, Placebo
Medical subject headings
Psychological Well-Being, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lion's mane blendDietary supplement

    1.8 gram per day of lions mane, consisting of 3 x 600mg capsules

  • Lion's mane and reishi blendDietary supplement

    1.8 gram per day of lions mane and reishi blend, consisting of 3 x 600mg capsules

  • PlaceboDietary supplement

    1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules

Study groups in NCT06406946
Study groupRoleWhat they receive
Lions ManeExperimentalLion's mane (1.8 gram per day, consisting of 3 x 600mgcapsules)
Receives: Dietary Supplement: Lion's mane blend
Mushroom BlendExperimentalLion's mane and reishi mushroom blend (1.8 gram per day, consisting of 3x600mg capsules)
Receives: Dietary Supplement: Lion's mane and reishi blend
PlaceboPlacebo comparator(1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety

    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).

    Measured: Baseline, following 28 days supplementation and 14 days after ceasing supplementation

Secondary outcomes (5)
  1. Anxiety

    Ratings of anxiety measured via the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The outcome of the anxiety subscale is reported as a score between 0 and 21. With scores divided into four stages: 0-7 (Normal), 8-10 (Mild), 11-15 (Moderate), 16-21 (Severe).

    Measured: Baseline, following, 7, 14, 21 and 28 days supplementation and 14 days after ceasing supplementation

  2. Stress

    Ratings of stress measured via the Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress. Scores 0-13 are considered low stress; 14-26 considered moderate stress; 27-40 considered high stress.

    Measured: Baseline and following 28 days supplementation

  3. Stress

    Subjective feelings of stress using Stress Visual Analogue Scales. Participants complete 4 visual analogue scales assessing how anxious, stressed, relaxed and calm they feel (Not at all (0) - Extremely (100)). An average 'stress' score is created using this data, this score ranges from 0 to 100, with a higher score indicating higher perceived stress.

    Measured: Baseline, following, 7, 14, 21 and 28 days supplementation and 14 days after ceasing supplementation

  4. Fatigue

    Subjective feelings of fatigue using the Chalder Fatigue Scale. Using Likert style scoring, individuals score in a range from 0 to 33. With a higher score indicating higher levels of fatigue.

    Measured: Baseline and following 28 days supplementation

  5. Self Esteem

    Ratings of self esteem using Rosenbergs Self Esteem Scale. An individual will score from 0 to 30. With a lower score indicating lower self esteem.

    Measured: Baseline and following 28 days supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2024
  2. Study start15 Apr 2024
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406946
Sponsor's protocol ID
65CG2
Status last verified
May 2024
First submitted
17 Apr 2024
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Smith EF, Docherty S. The effects of four-week supplementation of Lion's mane and a Lion's mane and Reishi blend on prioritised mood and wellbeing measures in young women. Front Nutr. 2026 Oct 20;13:1887408. doi: 10.3389/fnut.2026.1887408. eCollection 2026.

    PubMed 42978868

Questions about this trial

What is this clinical trial studying?

A study testing Lion's mane blend and Lion's mane and reishi blend in people with Well-Being, Psychological and Mood, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (time frame: Baseline, following 28 days supplementation and 14 days after ceasing supplementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06406946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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