Gut Health, Metabolic Health
Conditions
Brief summary
This dietary intervention study will assess the effect in healthy human volunteers of an E number which is a food additive and commonly used and consumed emulsifier, on gut function, gut inflammation and glucose metabolism. We will be using a powdered soy lecithin product in the food to compare a diet with and without this ingredient.
Detailed description
A dietary intervention study to investigate the effect, in healthy human volunteers, of dietary lecithin (soy lecithin), a commonly used/consumed emulsifier, on markers of gut function particularly bacterial translocation (assessed by measure of venous blood bacterial DNA, circulating lipopolysaccharide \[LPS\] binding protein and soluble CD14), gut inflammation (assessed by measurement of faecal calprotectin), gut microbiota activity/composition (faecal short-chain fatty acid \[SCFA\] profile and bacterial diversity \[16S ribosomal RNA genes\]) and glucose metabolism (measured by oral glucose tolerance test \[OGGT\], plasma fasted lipids and insulin).
Interventions
DIETARY_SUPPLEMENTSoya lecithin
The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices
Sponsors
Medical Research Council
University of Liverpool
University of Aberdeen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Diet trial with randomised sequence of delivery of two diets.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• BMI ranging from 27-40 kg/m2
Exclusion criteria
* Antibiotic use within the past 3 months (due to impact on gut microbiota) * Current Statin use * Current Aspirin use * Chronic inflammatory disorders (including rheumatoid arthritis, inflammatory bowel disease) * Food allergies or self-reported food sensitivity or intolerance * Diagnosis of diabetes * Pregnant or breastfeeding * Unsuitable veins for blood sampling * Inability to speak, read and understand English * Unable to comply to alcohol-free diet for 5 weeks * Consumption of nutrition supplements * Soy allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bacterial translocation | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | Assessment of change in bacterial translocation by venous blood bacterial DNA measured as responding to pre and post dietary treatment as gene copy number per ml but using more validated universal qPCR primer sets (including total bacteria, phyla- and class-specific primers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faecal volatile organics compounds | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Faecal short chain fatty acids | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Faecal bacterial 16S rRNA gene sequencing | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Plasma highly sensitive C-reactive protein | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Faecal calprotectin | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Plasma fasting blood glucose and up to 3 hours after OGTT | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Plasma fasted insulin profile and up to 2 hours postprandial OGTT | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Plasma fasting lipid profile | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | Triglycerides, high and low-density cholesterol will be assessed by Kone automated analyser |
| Plasma trimethylamine-N-oxide (TMAO) | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
| Plasma soluble CD14 and LPS binding protein | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion | — |
Countries
United Kingdom
Outcome results
None listed