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

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

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.

Study Overview

• Status: Completed
• Conditions: Gut Health; Metabolic Health
• Intervention / Treatment: Dietary supplement: Soya lecithin

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZD
    • The Rowett Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-emulsifier to Low-emulsifier; 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	Dietary supplement: Soya lecithin; The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices
Experimental: Low-emulsifier to High-emulsifier; 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	Dietary supplement: Soya lecithin; The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: Medical Research Council; University of Liverpool
• Investigators: Principal Investigator: Alexandra Johnstone, PhD, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 810 (Other Identifier: Altus/Alnara)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No