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

NCT ID: NCT05212545

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2022-09-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

10 g maltodextrin per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

maltodextrin taken daily for 4 weeks with water

Prebiotic Supplement

10 g Prebiotic supplement + maltodextrin per day

Group Type EXPERIMENTAL

Prebiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Prebiotic supplement taken daily for 4 weeks with water

Prebiotic combination

10 g prebiotic supplement+ prebiotic oligosaccharide per day

Group Type EXPERIMENTAL

Prebiotic combination

Intervention Type DIETARY_SUPPLEMENT

prebiotic oligosaccharides mixture taken daily for 4 weeks with water

prebiotic oligosaccharide

10 g maltodextrin + prebiotic oligosaccharide per day

Group Type EXPERIMENTAL

Prebiotic oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Prebiotic oligosaccharides taken daily for 4 weeks with water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

maltodextrin taken daily for 4 weeks with water

Intervention Type DIETARY_SUPPLEMENT

Prebiotic supplement

Prebiotic supplement taken daily for 4 weeks with water

Intervention Type DIETARY_SUPPLEMENT

Prebiotic combination

prebiotic oligosaccharides mixture taken daily for 4 weeks with water

Intervention Type DIETARY_SUPPLEMENT

Prebiotic oligosaccharides

Prebiotic oligosaccharides taken daily for 4 weeks with water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Reading

OTHER

Sponsor Role collaborator

Beneo-Institute

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert A Rastall, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Reading

Reading, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Jackson PP, Wijeyesekera A, Williams CM, Theis S, van Harsselaar J, Rastall RA. Inulin-type fructans and 2'fucosyllactose alter both microbial composition and appear to alleviate stress-induced mood state in a working population compared to placebo (maltodextrin): the EFFICAD Trial, a randomized, controlled trial. Am J Clin Nutr. 2023 Nov;118(5):938-955. doi: 10.1016/j.ajcnut.2023.08.016. Epub 2023 Aug 30.

Reference Type DERIVED
PMID: 37657523 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21017m-jhr

Identifier Type: -

Identifier Source: org_study_id