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

NCT03842514 | Completed

• 1 other identifier: 810
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Health; Metabolic Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

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

Dietary Supplement: Soya lecithin

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

Dietary Supplement: Soya lecithin

Interventions

Soya lecithin DIETARY_SUPPLEMENT

The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices

High-emulsifier to Low-emulsifier; Low-emulsifier to High-emulsifier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ranging from 27-40 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• Medical Research Council: collaborator
• University of Liverpool: collaborator

Study Sites (1)

The Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Interventions

bearberry, bladderwrack, borage oil, centella, fatty acid, fish oil, ginkgo biloba, melilotus, soya lecithin drug combination

Study Officials

• Alexandra Johnstone, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diet trial with randomised sequence of delivery of two diets.

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: May 1, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)