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

University of Aberdeen

Status: Completed

Conditions: Metabolic Health; Gut Health

Treatments: Dietary Supplement: Soya lecithin

Study type: Interventional

Funder types: Other

Identifiers

NCT03842514

810 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

High-emulsifier to Low-emulsifier

Experimental group

Description:

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

Treatment:

Dietary Supplement: Soya lecithin

Low-emulsifier to High-emulsifier

Experimental group

Description:

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

Treatment:

Dietary Supplement: Soya lecithin