NCT05315986

Exploration of Relationships Between Sleep, Gut Health and Cognition

The Gut-sleep-brain Axis: Targeting the Gut Microbiota and Sleep Quality by Individualized Non-pharmaceutical Approaches to Promote Healthy Ageing.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

Our study aims to build on emerging evidence showing relationships between gut health, sleep and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia complaints. Our study also aims to test the feasibility of using wearable and commercially available EEG headband technology to measure objective sleep quality in the home, which will allow for a reliable and ecologically more valid sleep research.

Detailed description

One-third of the UK adult population presents with disordered sleep, and the prevalence further increases with ageing. Disordered sleep has also been identified as a risk factor for dementia, which is alarming given that cases of dementia are predicted to triple across the world by 2050. Our study aims to build on emerging evidence showing relationships between gut health, sleep, and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia. The study aims to test the feasibility of using wearable sleep tracking EEG technology (DREEM3 device) to measure sleep quality in the home environment, which could contribute to a reliable but naturalistic and accessible future sleep research. The study is split into 4 phases: Screening phase: Participants will be asked to complete an online screening assessment to check for eligibility. Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their cognitive functions, psychological well-being, and postural control. They will be asked to provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a baseline measure for testing supplement adherence and wear the DREEM3 headband device and complete a sleep diary to track their sleep quality with a high accuracy in their habitual home environment. Intervention phase (4 weeks): Participants will be randomly assigned to 1 of 4 groups following a factorial design: Group 1: Food supplement \& ESE; Group 2: Food supplement \& No ESE (control); Group 3: Placebo (control) \& ESE, and Group 4: Placebo (control) \& No ESE (control). These groups will allow us to test the effectiveness of each non-pharmacological intervention for feasibility. Follow-up assessment (1 week - overlap with the last week of intervention): Participants will be asked to measure their sleep at home using the DREEM3 EEG device and complete a sleep diary, and finally will be re-tested for cognitive performance, psychological wellbeing, and postural control. A follow-up faecal sample and urine sample will be collected as well. This research predicts that it is feasible for sleep difficulties in older adults to be objectively assessed in the home environment and non-pharmacologically treated using food supplements and behavioural techniques. It endeavours to provide pilot evidence for the effectiveness of future individualized non-pharmaceutical sleep treatments in older people at risk of dementia.

Conditions

• Insomnia
• Sleep Disturbance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Saffr'Inside; 30mg	Ingestion of one gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.
BEHAVIORAL	Enhanced Sleep Education	Psycho-education based multi-component sleep intervention
DIETARY_SUPPLEMENT	Placebo food supplement	Placebo food supplement identical to the active gummy sweet of Saffr'Inside; 30mg, on a daily basis for 4 weeks.

Timeline

• Start date: 2022-04-29
• Primary completion: 2022-06-30
• Completion: 2022-12-15
• First posted: 2022-04-07
• Last updated: 2022-04-07