Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

NCT05239845 | Active Not Recruiting

• 1 other identifier: 35654
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.

Conditions

Sleep

Keywords

Gut Microbiome; Stress; Immune Function; Cognition

Outcome Measures

Primary Outcomes (1)

• Lab-recorded polysomnography- Sleep Quality

  percentage of time in staged sleep from total sleep recorded time

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

Secondary Outcomes (45)

• Lab-recorded polysomnography- Sleep onset latency

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

• Lab-recorded polysomnography- Total sleep time

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

• Lab-recorded polysomnography- Number of awakenings

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

• Lab-recorded polysomnography- Wake after sleep onset

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

• Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep

  Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

Study Arms (4)

Investigational Supplement 1 (INV-1)

ACTIVE COMPARATOR

The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days.

Dietary Supplement: Prebiotic

Investigational Supplement 1 (INV-2)

ACTIVE COMPARATOR

The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days.

Dietary Supplement: Prebiotic

Investigational Supplement 1 (INV-3)

ACTIVE COMPARATOR

The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days.

Dietary Supplement: Prebiotic

Control

PLACEBO COMPARATOR

The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days.

Other: Control

Interventions

Prebiotic DIETARY_SUPPLEMENT

The bioactive ingredients used in this study include bovine milk fat globule membrane (MFGM), bovine lactoferrin and a prebiotic blend of polydextrose and galactooligosaccharides (PDX/GOS).

Investigational Supplement 1 (INV-1); Investigational Supplement 1 (INV-2); Investigational Supplement 1 (INV-3)

Control OTHER

Maltodextrin

Control

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must self-assess themselves as being in good health.
• Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week)
• 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 prebiotic or probiotic products/supplements (including specifically oligosaccharides)
• 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
• 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
• Milk allergy

Sponsors & Collaborators

• Northumbria University: lead
• Reckitt Benckiser Group PLC: collaborator

Study Sites (2)

Northumbria Sleep Research, Northumbria University

Newcastle, United Kingdom

Location

Northumbria University

Newcastle, United Kingdom

Location

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Jason Ellis, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

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: February 4, 2022
• First Posted: February 15, 2022
• Study Start: March 3, 2022
• Primary Completion: June 28, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)