Gut HealthFADietsNCT03842514
Food Additives - Do Processed Diets Impact on Gut and Metabolic Health
A study testing Soya lecithin in people with Gut Health and Metabolic Health, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Health, Metabolic Health
- What is being tested?
- Soya lecithin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ranging from 27-40 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism
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.
Read the detailed 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).
- Conditions
- Gut Health, Metabolic Health
- Being tested
- Soya lecithin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soya lecithinDietary supplement
The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Soya lecithin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma soluble CD14 and LPS binding protein
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasting blood glucose and up to 3 hours after OGTT
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasted insulin profile and up to 2 hours postprandial OGTT
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasting lipid profile
Triglycerides, high and low-density cholesterol will be assessed by Kone automated analyser
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma trimethylamine-N-oxide (TMAO)
Measured: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 May 2019
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Diet trial with randomised sequence of delivery of two diets.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Alexandra Johnstone, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842514
- Sponsor's protocol ID
- 810
- Acronym
- FADiets
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Dietary Lecithin on Intestinal Permeability, Bacterial Translocation, Microbiota and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT03842514
- Acronym / sponsor ID
- FADiets / 810
- Conditions
- Gut Health, Metabolic Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Medical Research Council, University of Liverpool
- Study start
- 1 May 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Diet trial with randomised sequence of delivery of two diets.
| Arm | Type | Receives |
|---|---|---|
| High-emulsifier to Low-emulsifier | Experimental | Dietary Supplement: Soya lecithinPhase 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 |
| Low-emulsifier to High-emulsifier | Experimental | Dietary Supplement: Soya lecithinPhase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ranging from 27-40 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soya lecithinThe lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices | Dietary supplement | High-emulsifier to Low-emulsifier, Low-emulsifier to High-emulsifier |
Primary outcome
Change in bacterial translocation
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
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)
10 secondary outcomes
Faecal calprotectin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma soluble CD14 and LPS binding protein
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasting blood glucose and up to 3 hours after OGTT
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasted insulin profile and up to 2 hours postprandial OGTT
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma fasting lipid profile
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Plasma trimethylamine-N-oxide (TMAO)
Time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Gut Health
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Johnstone, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soya lecithin in people with Gut Health and Metabolic Health, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bacterial translocation (time frame: Samples collected at baseline and after each 14 day intervention period. Will be assessed no later than 48 months post final volunteer completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.