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

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.

Study Overview

• Status: Completed
• Conditions: Mood
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Prebiotic supplement; Dietary supplement: Prebiotic combination; Dietary supplement: Prebiotic oligosaccharides

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?".

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG6 6DZ
    • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Volunteer is healthy at the time of pre-examination
• Possess mild/moderately elevated levels of stress
• Volunteer is aged ≥ 18 to ≤ 45 years at the time of pre-examination
• Volunteer's BMI is ≥ 18.5 and ≤ 29.9
• Volunteer has a stool frequency of at least 3 bowel movements per week
• Volunteer is able and willing to comply with the study instructions
• Volunteer is suitable for participation in the study according to the investigator/study personnel
• Written informed consent is given by volunteer

Exclusion Criteria:

• No command of any local language
• Previously or currently diagnosed neurological or psychiatric disorders
• Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes
• Gastrointestinal disorders including IBS, IBD or other conditions that might affect the gut environment
• Food allergies or intolerances
• Using drugs (e.g. antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
• Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention
• Volunteers currently involved or will be involved in another clinical or food study
• History of drug (recreational) or alcohol abuse.
• Use of anti-depressants medication including selective serotonin receptor inhibitors or Amitriptyline for 3 months prior to commencing the trial
• Received bowel preparation for investigative procedures in the 4 weeks prior to the study
• Undergone surgical resection of any part of the bowel.
• pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 10 g maltodextrin per day	Dietary supplement: Placebo; maltodextrin taken daily for 4 weeks with water
Experimental: Prebiotic Supplement; 10 g Prebiotic supplement + maltodextrin per day	Dietary supplement: Prebiotic supplement; Prebiotic supplement taken daily for 4 weeks with water
Experimental: Prebiotic combination; 10 g prebiotic supplement+ prebiotic oligosaccharide per day	Dietary supplement: Prebiotic combination; prebiotic oligosaccharides mixture taken daily for 4 weeks with water
Experimental: prebiotic oligosaccharide; 10 g maltodextrin + prebiotic oligosaccharide per day	Dietary supplement: Prebiotic oligosaccharides; Prebiotic oligosaccharides taken daily for 4 weeks with water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bifidobacterium spp in stool samples	Bifidobacterium spp. will be assessed in stool samples by molecular biological methods	4 weeks
Anxiety with State-Trait Anxiety Inventory questionnaire	Anxiety will be assessed with anxiety questionnaire at baseline and at the end of intervention	4 weeks
Depression with Beck's Depression Inventory questionnaire	Depression will be assessed with depression questionnaire at baseline and at the end of intervention	4 weeks
Salivary IgA	Salivary IgA will be assessed by ELISA at baseline and at the end of intervention	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total bacteria in stool samples	Total bacteria will be assessed in stool samples by molecular biological methods	4 weeks
Changes in microbiota composition	Microbiota composition at baseline and end will be assessed by 16S rRNA gene sequencing	4 weeks
Stool frequency	Stool frequency will be assessed as effective number of bowel movements in a daily diary during baseline and intervention periods	5 weeks
Stool consistency according to Bristol Stool Form Scale	Stool consistency will be assessed in a daily diary during baseline and intervention periods	5 weeks
Urinary Metabolites (organic compounds) concentration	Urinary Metabolites concentration will be assessed at baseline and end with NMR	4 weeks
Gastrointestinal sensations (bloating)	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)	5 weeks
Gastrointestinal sensations (flatulence)	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)	5 weeks
Gastrointestinal sensations (abdominal pain)	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)	5 weeks
Gastrointestinal sensations (fullness)	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)	5 weeks
Sleep quality via The Pittsburgh Sleep Quality Index	Sleep quality will be assessed at baseline and end with The Pittsburgh Sleep Quality Index questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: Beneo-Institute
• Collaborators: University of Reading
• Investigators: Principal Investigator: Robert A Rastall, Prof, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21017m-jhr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No