Actively Recruiting
Mushrooms, Mood and Mental Wellbeing in Gen Z Women
Led by Northumbria University · Updated on 2024-05-09
135
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Mushrooms, Mood and Mental Wellbeing in Gen Z Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Identify as a woman
- Are aged 18 to 26 years at the time of giving consent (born between 1997 and 2013)
- Rate themselves as stressed and/or anxious
- Be a native or fluent English speaker
You will not qualify if you...
- Have medical conditions that impact study participation except controlled hayfever, asthma, thyroid disorders, high blood pressure, high cholesterol, reflux, dyslexia/dyscalculia, ADHD, or autism
- Are taking prescription medications except contraceptives and as-needed asthma or hay fever treatments; neurological medications allowed if taken consistently for at least 3 months
- Have relevant food allergies, intolerances, or sensitivities
- Consume more than 500 mg caffeine per day
- Have taken dietary supplements in the last 4 weeks unless prescribed Vitamin D or iron for at least 4 weeks
- Are pregnant, seeking pregnancy, or lactating
- Have taken antibiotics in the past 4 weeks
- Are or have been in other clinical or nutrition studies in the past 4 weeks
- Have had alcohol or drug abuse treatment in the past 12 months
- Have had a psychiatric disorder diagnosis or treatment including anxiety or depression in the past 12 months
- Experience frequent migraines requiring medication (1 or more per month)
- Have sleep disorders or use sleep aids
- Have any active infections
- Are unable to comply with treatment consumption
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brain, Performance and Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Actively Recruiting
Research Team
S
Sarah Docherty, PhD
CONTACT
E
Ellen Smith, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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