Mushrooms, Mood and Mental Wellbeing in Gen Z Women

NCT06406946 | Recruiting

• 1 other identifier: 65CG2
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Well-Being, Psychological; Mood; Anxiety; Stress

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (5)

• Anxiety

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

• Stress

  Baseline and following 28 days supplementation

• Stress

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

• Fatigue

  Baseline and following 28 days supplementation

• Self Esteem

  Baseline and following 28 days supplementation

Study Arms (3)

Lions Mane

EXPERIMENTAL

Lion's mane (1.8 gram per day, consisting of 3 x 600mgcapsules)

Dietary Supplement: Lion's mane blend

Mushroom Blend

EXPERIMENTAL

Lion's mane and reishi mushroom blend (1.8 gram per day, consisting of 3x600mg capsules)

Dietary Supplement: Lion's mane and reishi blend

Placebo

PLACEBO COMPARATOR

(1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules).

Dietary Supplement: Placebo

Interventions

Lion's mane blend DIETARY_SUPPLEMENT

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

Lions Mane

Lion's mane and reishi blend DIETARY_SUPPLEMENT

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

Mushroom Blend

Placebo DIETARY_SUPPLEMENT

1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Participants must identify as a woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Study Officials

• Sarah Docherty, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Docherty, PhD

CONTACT

0191 227 3484; sarah4.docherty@northumbria.ac.uk

Ellen Smith, PhD

CONTACT

ellen.f.smith@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 9, 2024
• Study Start: April 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

GB (1)