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Exploration of Relationships Between Sleep, Gut Health and Cognition

NCT05315986 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-04-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of East Anglia

    lead OTHER

Principal Investigators

  • Alpar S Lazar, PhD · University of East Anglia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2022-06-30
Completion
2022-12-15

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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 NCT05315986 on ClinicalTrials.gov