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Mushrooms, Mood and Mental Wellbeing in Gen Z Women

NCT06406946 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-05-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Northumbria University

    lead OTHER

Principal Investigators

  • Sarah Docherty, PhD · Northumbria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06406946 on ClinicalTrials.gov