Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406946
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-17
Brief Title:
Mushrooms Mood and Mental Wellbeing in Gen Z Women
Sponsor:
Northumbria University
Organization:
Northumbria University
Study Overview
Official Title:
Investigating the Effects of Lions Mane Mushroom and a Mushroom Blend on Wellbeing in StressedAnxious Gen Z Women
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lions mane mushroom mane 18 gram per day consisting of 3 x 600mgcapsules a blend of lions mane mushroom and reishi mushroom 18 gram per day consisting of 3x600mg capsules or placebo 18-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 Rosenbergs 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 andor 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
The study will follow a randomized double-blind placebo-controlled parallel group design Participants will receive either lions mane mushroom mane 18 gram per day consisting of 3 x 600mgcapsules a blend of lions mane mushroom and reishi mushroom 18 gram per day consisting of 3x600mg capsules or placebo 18-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 Rosenbergs 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 andor 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
Detailed Description:
The study will follow a randomized double-blind placebo-controlled parallel group design Participants will receive either lions mane a blend of lions 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 involveobtaining 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 weightwaist-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 Rosenbergs 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 moodwellbeing 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 andor 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
Participants will initially attend a virtual screening session conducted via telephone call or Microsoft Teams this session will involveobtaining 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 weightwaist-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 Rosenbergs 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 moodwellbeing 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None