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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| University of Liverpool | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-emulsifier to Low-emulsifier | Experimental | Phase 1: No intervention - 7 days food diary (recording at home, usual diet) Phase 2: 14 days high-emulsifier (soya lecithin) low-calorie diet at 100% resting metabolic rate Phase 3: No intervention - 7 days washout with usual diet Phase 4: 14 days low-emulsifier low-calorie diet at 100% resting metabolic rate |
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| Low-emulsifier to High-emulsifier | Experimental | Phase 1: No intervention - 7 days food diary (recording at home, usual diet) Phase 2: 14 days low-emulsifier low-calorie diet at 100% resting metabolic rate Phase 3: No intervention - 7 days washout with usual diet Phase 4: 14 days high-emulsifier( soya lecithin) low-calorie diet at 100% resting metabolic rate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soya lecithin | Dietary Supplement | The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
• BMI ranging from 27-40 kg/m2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Johnstone, PhD | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rowett Institute | Aberdeen | AB25 2ZD | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2019 | Feb 18, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| C119572 | bearberry, bladderwrack, borage oil, centella, fatty acid, fish oil, ginkgo biloba, melilotus, soya lecithin drug combination |
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Diet trial with randomised sequence of delivery of two diets.
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| 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 |
| 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 |
| 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 | Triglycerides, high and low-density cholesterol will be assessed by Kone automated analyser | 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) | Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion |