Gut Health Clinical Trial
— FADietsOfficial title:
Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism
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 |
Verified date | March 2020 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Rowett Institute | Aberdeen |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen | Medical Research Council, University of Liverpool |
United Kingdom,
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 |
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 |