AzTrials
AzTrials

MoodNCT05212545

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

A study testing Prebiotic supplement, Prebiotic combination and Prebiotic oligosaccharides in people with Mood, run by Beneo-Institute at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Mood
What is being tested?
Prebiotic supplement, Prebiotic combination and Prebiotic oligosaccharides
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteUnited Kingdom
Study dates
12 Jan 2022to 19 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Reading

    Reading, RG6 6DZ

Other trials in United Kingdom

About this study

Official 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

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.

Read the 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?".

Conditions
Mood
Being tested
Placebo, Prebiotic supplement, Prebiotic combination, Prebiotic oligosaccharides

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    maltodextrin taken daily for 4 weeks with water

  • Prebiotic supplementDietary supplement

    Prebiotic supplement taken daily for 4 weeks with water

  • Prebiotic combinationDietary supplement

    prebiotic oligosaccharides mixture taken daily for 4 weeks with water

  • Prebiotic oligosaccharidesDietary supplement

    Prebiotic oligosaccharides taken daily for 4 weeks with water

Study groups in NCT05212545
Study groupRoleWhat they receive
PlaceboPlacebo comparator10 g maltodextrin per day
Receives: Dietary Supplement: Placebo
Prebiotic SupplementExperimental10 g Prebiotic supplement + maltodextrin per day
Receives: Dietary Supplement: Prebiotic supplement
Prebiotic combinationExperimental10 g prebiotic supplement+ prebiotic oligosaccharide per day
Receives: Dietary Supplement: Prebiotic combination
prebiotic oligosaccharideExperimental10 g maltodextrin + prebiotic oligosaccharide per day
Receives: Dietary Supplement: Prebiotic oligosaccharides

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bifidobacterium spp in stool samples

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

    Measured: 4 weeks

  2. Anxiety with State-Trait Anxiety Inventory questionnaire

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

    Measured: 4 weeks

  3. Depression with Beck's Depression Inventory questionnaire

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

    Measured: 4 weeks

  4. Salivary IgA

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

    Measured: 4 weeks

Secondary outcomes (10)

  1. Total bacteria in stool samples

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

    Measured: 4 weeks

  2. Changes in microbiota composition

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

    Measured: 4 weeks

  3. Stool frequency

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

    Measured: 5 weeks

  4. Stool consistency according to Bristol Stool Form Scale

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

    Measured: 5 weeks

  5. Urinary Metabolites (organic compounds) concentration

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

    Measured: 4 weeks

  6. 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)

    Measured: 5 weeks

  7. 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)

    Measured: 5 weeks

  8. 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)

    Measured: 5 weeks

  9. 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)

    Measured: 5 weeks

  10. Sleep quality via The Pittsburgh Sleep Quality Index

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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start12 Jan 2022
  3. Primary completion30 Jun 2022
  4. Study completion19 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212545
Sponsor's protocol ID
21017m-jhr
Status last verified
Dec 2022
First submitted
3 Jan 2022
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37657523

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic supplement, Prebiotic combination and Prebiotic oligosaccharides in people with Mood, run by Beneo-Institute at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bifidobacterium spp in stool samples (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05212545, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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