NCT05212545

Effects of Prebiotics on Intestinal Colonization and Mood in a University Cohort

Randomised Double-blind 4-arm Parallel, Placebo-controlled Trial Investigating the Effects of Prebiotics Alone or in a Combination on Intestinal Colonization and Ability to Influence Mood in a University Cohort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Beneo-Institute · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

There is a growing interest within the scientific community of whether prebiotics can aid in clinical outcomes including mood via modulation of the gut microbiota and its resulting metabolites via the gut-brain axis. This is especially prevalent given that mental health conditions are associated with cost and burden on the health care system. Yet, to date very few studies have investigated the potential effects of prebiotics to influence mood via the modulation of the gut microbiota with previous studies recording mixed results indicating further work in this area would be highly beneficial.

Detailed description

Several reports have suggested that poor mental health among university students is on the increase. Factors driving this; including academic pressure, overdemanding workloads, financial concerns, and peer pressure; can adversely affect academic performance and self-worth. Thus, there is an increasing need to develop new strategies to help tackle these modalities while also reducing the burden on the health system. In recent years there has been increasing interest in the bi-directional relationship that exists between the gut and the brain, a term coined the gut-brain axis, and it is suggested to play a role in influencing mood via chemical messengers. As diet is key manipulator of the gut microbiota one way to influence the composition of the gut is via diet and the use of functional foods including prebiotic oligosaccharides. The idea that functional foods like prebiotics may help to affect mood holds particular appeal due to them being relatively free of side effects, cheap, readily accessible and possessing additional health benefits including improving bowel transit function and improving satiety amongst others. Yet, to date previous research on the potential for prebiotics has produced mixed results due to differences in the populations tested, doses and types of prebiotics used, and means of assessing changes in mood suggesting further work in this area would be highly beneficial. Therefore, this present study aims to address the question "can manipulation of the gut microbiota using prebiotic oligosaccharides alone or in combination influence mental state in a taught university student population?".

Conditions

• Mood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	maltodextrin taken daily for 4 weeks with water
DIETARY_SUPPLEMENT	Prebiotic supplement	Prebiotic supplement taken daily for 4 weeks with water
DIETARY_SUPPLEMENT	Prebiotic combination	prebiotic oligosaccharides mixture taken daily for 4 weeks with water
DIETARY_SUPPLEMENT	Prebiotic oligosaccharides	Prebiotic oligosaccharides taken daily for 4 weeks with water

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-06-30
• Completion: 2022-09-19
• First posted: 2022-01-28
• Last updated: 2022-12-20

Locations

1 site across 1 country: United Kingdom