Status:
COMPLETED
Effects of Prebiotics on Intestinal Colonization and Mood in a University Cohort
Lead Sponsor:
Beneo-Institute
Collaborating Sponsors:
University of Reading
Conditions:
Mood
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05212545
Start Date
January 12 2022
End Date
September 19 2022
Last Update
December 20 2022
Active Locations (1)
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1
University of Reading
Reading, United Kingdom, RG6 6DZ