Clinical trial NCT03842514: Food Additives - Do Processed Diets Impact on Gut and Metabolic Health
Official title: Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Metabolic Health
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: University of Liverpool
First posted: 2019-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Diet trial with randomised sequence of delivery of two diets.
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in bacterial translocation
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Secondary outcomes:
measure: Faecal calprotectin
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Faecal volatile organics compounds
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Faecal short chain fatty acids
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Faecal bacterial 16S rRNA gene sequencing
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma highly sensitive C-reactive protein
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma soluble CD14 and LPS binding protein
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma fasting blood glucose and up to 3 hours after OGTT
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma fasted insulin profile and up to 2 hours postprandial OGTT
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma fasting lipid profile
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
measure: Plasma trimethylamine-N-oxide (TMAO)
timeFrame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: The Rowett Institute
Study officials:
affiliation: University of Aberdeen
name: Alexandra Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References: