Food Additives - Do Processed Diets Impact on Gut and Metabolic Health
- Conditions
- Metabolic HealthGut Health
- Interventions
- Dietary Supplement: Soya lecithin
- Registration Number
- NCT03842514
- Lead Sponsor
- University of Aberdeen
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
• BMI ranging from 27-40 kg/m2
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High-emulsifier to Low-emulsifier Soya lecithin 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 Low-emulsifier to High-emulsifier Soya lecithin 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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
Trial Locations
- Locations (1)
The Rowett Institute
🇬🇧Aberdeen, United Kingdom