Food Additives - Do Processed Diets Impact on Gut and Metabolic Health

Gut Health Clinical Trial

— FADiets  

Official title:

Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842514
• Other study ID #: 810
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: March 2020
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gut Health
• Metabolic Health

Intervention

Dietary Supplement:
• Soya lecithin
The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices

Locations

Country	Name	City	State
United Kingdom	The Rowett Institute	Aberdeen

Sponsors (3)

Lead Sponsor	Collaborator
University of Aberdeen	Medical Research Council, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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