Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
The proposed protocol will provide a simple but robust intervention study using a synbiotic (pre and probiotic combination) in order to improve our understanding of the mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome. This pilot study will comprise a controlled randomised intervention in which participants will be grouped into the active synbiotic arm or the control arm. The ratios will be 10g of the prebiotic supplement and 170ml of kefir. Randomisation will control for equal distribution of age and biological sex; characteristics that may confound between group comparisons and will be assessed by analysis of baseline data.
Sponsors
Elizabeth Simpson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomised Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 depression |
| Changes 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 |
Countries
United Kingdom
Outcome results
None listed