University of Reading
Reading, RG6 6DZ, United Kingdom
NCT Number: NCT05212545
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Reading, RG6 6DZ, United Kingdom
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?".
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
maltodextrin taken daily for 4 weeks with water
Prebiotic supplement taken daily for 4 weeks with water
prebiotic oligosaccharides mixture taken daily for 4 weeks with water
Prebiotic oligosaccharides taken daily for 4 weeks with water
Time frame: 4 weeks
Bifidobacterium spp. will be assessed in stool samples by molecular biological methods
Time frame: 4 weeks
Anxiety will be assessed with anxiety questionnaire at baseline and at the end of intervention
Time frame: 4 weeks
Depression will be assessed with depression questionnaire at baseline and at the end of intervention
Time frame: 4 weeks
Salivary IgA will be assessed by ELISA at baseline and at the end of intervention
Time frame: 4 weeks
Total bacteria will be assessed in stool samples by molecular biological methods
Time frame: 4 weeks
Microbiota composition at baseline and end will be assessed by 16S rRNA gene sequencing
Time frame: 5 weeks
Stool frequency will be assessed as effective number of bowel movements in a daily diary during baseline and intervention periods
Time frame: 5 weeks
Stool consistency will be assessed in a daily diary during baseline and intervention periods
Time frame: 4 weeks
Urinary Metabolites concentration will be assessed at baseline and end with NMR
Time frame: 5 weeks
Gastrointestinal sensations (bloating) will be assessed in a daily diary during baseline and intervention periods on a 4-point Likert scale (higher scores indicate higher sensation)
Time frame: 5 weeks
Gastrointestinal sensations (flatulence) will be assessed in a daily diary during baseline and intervention periods on a 4-point Likert scale (higher scores indicate higher sensation)
Time frame: 5 weeks
Gastrointestinal sensations (abdominal pain) will be assessed in a daily diary during baseline and intervention periods on a 4-point Likert scale (higher scores indicate higher sensation)
Time frame: 5 weeks
Gastrointestinal sensations (fullness) will be assessed in a daily diary during baseline and intervention periods on a 4-point Likert scale (higher scores indicate higher sensation)
Time frame: 4 weeks
Sleep quality will be assessed at baseline and end with The Pittsburgh Sleep Quality Index questionnaire
Beneo-Institute
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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