Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.

NCT07369869 | Not Yet Recruiting

• 1 other identifier: 000000
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.

Conditions

Stress; Sleep; Cognition; Nutrition; Microbiome

Keywords

sleep; gut health; cognition; stress

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency (SE)

  Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed.

  Change from Baseline to end of supplementation period at 28 days

Secondary Outcomes (14)

• Actigraphy - Sleep onset latency

  Change from baseline following 28 days of supplement consumption

• Actigraphy - Sleep efficiency

  Change from baseline following 28 days of supplement consumption

• Actigraphy - Number of awakenings

  Change from baseline following 28 days of supplement consumption

• Actigraphy - Wake after sleep onset (WASO)

  Change from baseline following 28 days of supplement consumption

• COMPASS global performance measures

  Change from baseline following 28 days of supplement consumption

Study Arms (3)

Arm 1

EXPERIMENTAL

Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days.

Dietary Supplement: Proprietary 'active' composition 1

Arm 2

EXPERIMENTAL

Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days.

Dietary Supplement: Proprietary 'active' composition 2

Control

PLACEBO COMPARATOR

Participants will be randomly allocated to consume control supplement for 28 days.

Dietary Supplement: Inactive control supplement

Interventions

Proprietary 'active' composition 1 DIETARY_SUPPLEMENT

A proprietary orally administered dietary supplement consisting of standardized ingredients.

Arm 1

Proprietary 'active' composition 2 DIETARY_SUPPLEMENT

A proprietary orally administered dietary supplement consisting of standardized ingredients.

Arm 2

Inactive control supplement DIETARY_SUPPLEMENT

Flavored vehicle

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must self-assess themselves as being in good health.
• Aged 25 to 60 years at the time of randomisation
• Fluent in English
• Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI).

You may not qualify if:

• Member of own household currently participating in this trial
• Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
• History of seizures or epilepsy
• Shift working or have a history of shift work within the previous six months
• Currently, or within the previous 8 weeks, consuming any nutritional supplements.
• Participation in any other intervention research trials
• Sleeping at a location other than their usual residence more than two nights per week during participation
• Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
• Current or recent mood disturbances or Axis I disorders (descriptions will be given)
• Current misuse of alcohol and/or drugs
• Current smoker
• Recent (within the last 12 weeks) infection and/or use of antibiotic medication
• Pregnant, seeking to become pregnant or lactating
• Those using (including within the last 2 weeks) proton-pump inhibitors

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University- Northumbria Sleep center and NUTRAN

Newcastle upon Tyne, United Kingdom

Location

Study Officials

• Professor Jason Ellis, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Alfonso-Miller, MD

CONTACT

+44 01912274149; pam.alfonso-miller@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)