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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-03-04

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gut Health Metabolic Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Diet trial with randomised sequence of delivery of two diets.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Soya lecithin

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Soya lecithin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Soya lecithin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes