Clinical trial NCT06480812: The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
Official title: The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.

Detailed description: The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.

Specific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.

Specific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
* Have a smart phone in order to download apps on phone

Exclusion Criteria:

* Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)
* Have lactose intolerance
* Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.
* Are currently taking fibre or probiotic supplements
* Are taking any prescribed medication
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
* Are pregnant or breast feeding
* Currently have a diagnosed psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Have taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Primary outcomes:
measure: Change in systemic inflammatory profile
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in gut microbiome profile
timeFrame: 6 weeks
measure: Changes in short chain fatty acids (SCFAs)
timeFrame: 6 weeks
measure: Mental Wellbeing as measured by validated questionnaires
timeFrame: 6 weeks
measure: Changes in skin microbiome profile
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Amrita Vijay, PhD
role: PRINCIPAL_INVESTIGATOR
References: