The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Synbiotic
- 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
- Arm && Interventions
Group Intervention Description Synbiotic arm Synbiotic Synbiotic mixure (10g prebiotic fibre + 170ml kefir) will be randomly allocated to eligible participants in order to test specific effects of the synbiotic mixture on gut microbiome composition and metabolic markers. Control Synbiotic Individuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle.
- 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