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

Northumbria University

Status: Active, not recruiting

Conditions: Sleep

Treatments: Dietary Supplement: Prebiotic; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05239845

35654

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 4 patient groups, including a placebo group

Investigational Supplement 1 (INV-1)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prebiotic

Investigational Supplement 1 (INV-2)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prebiotic

Investigational Supplement 1 (INV-3)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prebiotic

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Control