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RECRUITING
NCT06406946
NA

Mushrooms, Mood and Mental Wellbeing in Gen Z Women

Sponsor: Northumbria University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2024-04-15

Completion Date

2025-02

Last Updated

2024-05-09

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Lion's mane blend

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

DIETARY_SUPPLEMENT

Lion's mane and reishi blend

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

DIETARY_SUPPLEMENT

Placebo

1.8-gram microcrystalline cellulose placebo powder, 3x600mg capsules

Locations (1)

Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom