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Completed

NCT Number: NCT05212545

Effects of Prebiotics on Intestinal Colonization and 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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, RG6 6DZ, United Kingdom

About this study

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?".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

maltodextrin taken daily for 4 weeks with water

Prebiotic supplement

Dietary Supplement

Prebiotic supplement taken daily for 4 weeks with water

Prebiotic combination

Dietary Supplement

prebiotic oligosaccharides mixture taken daily for 4 weeks with water

Prebiotic oligosaccharides

Dietary Supplement

Prebiotic oligosaccharides taken daily for 4 weeks with water

Primary outcomes

  1. Bifidobacterium spp in stool samples

    Time frame: 4 weeks

    Bifidobacterium spp. will be assessed in stool samples by molecular biological methods

  2. Anxiety with State-Trait Anxiety Inventory questionnaire

    Time frame: 4 weeks

    Anxiety will be assessed with anxiety questionnaire at baseline and at the end of intervention

  3. Depression with Beck's Depression Inventory questionnaire

    Time frame: 4 weeks

    Depression will be assessed with depression questionnaire at baseline and at the end of intervention

  4. Salivary IgA

    Time frame: 4 weeks

    Salivary IgA will be assessed by ELISA at baseline and at the end of intervention

Secondary outcomes

  1. Total bacteria in stool samples

    Time frame: 4 weeks

    Total bacteria will be assessed in stool samples by molecular biological methods

  2. Changes in microbiota composition

    Time frame: 4 weeks

    Microbiota composition at baseline and end will be assessed by 16S rRNA gene sequencing

  3. Stool frequency

    Time frame: 5 weeks

    Stool frequency will be assessed as effective number of bowel movements in a daily diary during baseline and intervention periods

  4. Stool consistency according to Bristol Stool Form Scale

    Time frame: 5 weeks

    Stool consistency will be assessed in a daily diary during baseline and intervention periods

  5. Urinary Metabolites (organic compounds) concentration

    Time frame: 4 weeks

    Urinary Metabolites concentration will be assessed at baseline and end with NMR

  6. Gastrointestinal sensations (bloating)

    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)

  7. Gastrointestinal sensations (flatulence)

    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)

  8. Gastrointestinal sensations (abdominal pain)

    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)

  9. Gastrointestinal sensations (fullness)

    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)

  10. Sleep quality via The Pittsburgh Sleep Quality Index

    Time frame: 4 weeks

    Sleep quality will be assessed at baseline and end with The Pittsburgh Sleep Quality Index questionnaire

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Collaborators

  • University of Reading

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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