The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
- Conditions
- Healthy
- Registration Number
- NCT06480812
- Lead Sponsor
- Elizabeth Simpson
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in systemic inflammatory profile 6 weeks Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.
- Secondary Outcome Measures
Name Time Method Change in gut microbiome profile 6 weeks Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period
Changes in short chain fatty acids (SCFAs) 6 weeks Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period
Mental Wellbeing as measured by validated questionnaires 6 weeks The Hospital Anxiety and Depression Survey (HADS) was used to assess subjective measures of anxiety and depression. The scores for each subscale (HADS-Anxiety (A) and HADS-Depression (D)) range from 0 to 21. The cut-off scores range from:
0-7: Normal (no significant symptoms) 8-10: Borderline or mild symptoms 11-21: Clinically significant anxiety or depressionChanges in skin microbiome profile 6 weeks Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period
Trial Locations
- Locations (1)
University of Nottingham
🇬🇧Nottingham, United Kingdom
University of Nottingham🇬🇧Nottingham, United Kingdom