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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices
The Rowett Institute
Aberdeen, United Kingdom
Change in bacterial translocation
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)
Time frame: 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
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Faecal volatile organics compounds
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
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Plasma fasting blood glucose and up to 3 hours after OGTT
Time frame: 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
Time frame: 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
Triglycerides, high and low-density cholesterol will be assessed by Kone automated analyser
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma trimethylamine-N-oxide (TMAO)
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion