Mushrooms, Mood and Mental Wellbeing in Gen Z Women

Anxiety Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Mood
• Stress

• NCT number: NCT06406946
• Study type: Interventional
• Source: Northumbria University
• Contact: Sarah Docherty, PhD
• Phone: 0191 227 3484
• Email: sarah4.docherty@northumbria.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Completion date: February 2025