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

NCT05212545 | Completed

• 1 other identifier: 21017m-jhr
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mood

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Total bacteria in stool samples

  4 weeks

• Changes in microbiota composition

  4 weeks

• Stool frequency

  5 weeks

• Stool consistency according to Bristol Stool Form Scale

  5 weeks

• Urinary Metabolites (organic compounds) concentration

  4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

10 g maltodextrin per day

Dietary Supplement: Placebo

Prebiotic Supplement

EXPERIMENTAL

10 g Prebiotic supplement + maltodextrin per day

Dietary Supplement: Prebiotic supplement

Prebiotic combination

EXPERIMENTAL

10 g prebiotic supplement+ prebiotic oligosaccharide per day

Dietary Supplement: Prebiotic combination

prebiotic oligosaccharide

EXPERIMENTAL

10 g maltodextrin + prebiotic oligosaccharide per day

Dietary Supplement: Prebiotic oligosaccharides

Interventions

Placebo DIETARY_SUPPLEMENT

maltodextrin taken daily for 4 weeks with water

Placebo

Prebiotic supplement DIETARY_SUPPLEMENT

Prebiotic supplement taken daily for 4 weeks with water

Prebiotic Supplement

Prebiotic combination DIETARY_SUPPLEMENT

prebiotic oligosaccharides mixture taken daily for 4 weeks with water

Prebiotic combination

Prebiotic oligosaccharides DIETARY_SUPPLEMENT

Prebiotic oligosaccharides taken daily for 4 weeks with water

prebiotic oligosaccharide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beneo-Institute: lead
• University of Reading: collaborator

Study Sites (1)

University of Reading

Reading, RG6 6DZ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37657523 DERIVED

Study Officials

• Robert A Rastall, Prof

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 28, 2022
• Study Start: January 12, 2022
• Primary Completion: June 30, 2022
• Study Completion: September 19, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)