Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03842514
Other study ID # 810
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05931471 - Yogurt and GI Health N/A
Recruiting NCT06122571 - A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health N/A
Completed NCT05364437 - Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort N/A
Recruiting NCT06419231 - Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms N/A
Recruiting NCT06159088 - Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula N/A
Recruiting NCT06404749 - Fungal Fiber for Gut Health N/A
Not yet recruiting NCT06433310 - Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study Early Phase 1
Completed NCT00696098 - Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission N/A
Completed NCT01656499 - Effect of AXOS on the Colon Metabolism in Healthy Volunteers Phase 2
Completed NCT02440503 - How Infant Diets Would Affect Growth in Early Childhood N/A
Not yet recruiting NCT06396728 - Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults N/A
Active, not recruiting NCT06023082 - A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management N/A
Completed NCT05051501 - The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population Phase 2
Completed NCT05488886 - Bioavailability of Aronia Berry Polyphenols N/A
Completed NCT05876845 - A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health N/A
Recruiting NCT04195425 - Breastfeeding and Gut Health
Completed NCT05952232 - A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut. N/A
Recruiting NCT03624569 - Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome N/A
Recruiting NCT05809466 - The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults N/A
Completed NCT05837754 - A Study to Assess the Gut Health Effects of Oil Compound on Healthy Adults N/A