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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic arm | Active Comparator | 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. |
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| Control | Placebo Comparator | Individuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systemic inflammatory profile | Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiome profile | Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period | 6 weeks |
| Changes in short chain fatty acids (SCFAs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amrita Vijay, PhD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Nottingham | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41094562 | Derived | Vijay A, Simpson L, Tooley M, Turley S, Kouraki A, Kelly A, Menni C, Armstrong J, Jones S, Valdes AM. The anti-inflammatory effects of three different dietary supplement interventions. J Transl Med. 2025 Oct 16;23(1):1081. doi: 10.1186/s12967-025-07167-x. |
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All data arising from the current study will be fully anonymised and used for publication purposes
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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Randomised Controlled
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Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period
| 6 weeks |
| Mental Wellbeing as measured by validated questionnaires | 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 | 6 weeks |
| Changes in skin microbiome profile | Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period | 6 weeks |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |