Effects of Prebiotics on Intestinal Colonization and Mood in a University Cohort
NCT ID: NCT05212545
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2022-01-12
2022-09-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
10 g maltodextrin per day
Placebo
maltodextrin taken daily for 4 weeks with water
Prebiotic Supplement
10 g Prebiotic supplement + maltodextrin per day
Prebiotic supplement
Prebiotic supplement taken daily for 4 weeks with water
Prebiotic combination
10 g prebiotic supplement+ prebiotic oligosaccharide per day
Prebiotic combination
prebiotic oligosaccharides mixture taken daily for 4 weeks with water
prebiotic oligosaccharide
10 g maltodextrin + prebiotic oligosaccharide per day
Prebiotic oligosaccharides
Prebiotic oligosaccharides taken daily for 4 weeks with water
Interventions
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Placebo
maltodextrin taken daily for 4 weeks with water
Prebiotic supplement
Prebiotic supplement taken daily for 4 weeks with water
Prebiotic combination
prebiotic oligosaccharides mixture taken daily for 4 weeks with water
Prebiotic oligosaccharides
Prebiotic oligosaccharides taken daily for 4 weeks with water
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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University of Reading
OTHER
Beneo-Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Robert A Rastall, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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University of Reading
Reading, , United Kingdom
Countries
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References
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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.
Other Identifiers
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21017m-jhr
Identifier Type: -
Identifier Source: org_study_id