HealthyNCT03840746
Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)
A study testing Tomato, onion and lovage soup (TOL) and TOL soup with inulin in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage \& onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tomato, onion and lovage soup (TOL) and TOL soup with inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2018to 30 Sep 2019
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
- BMI>=25
- Not on antibiotics within 3 months of starting of study
- No medication likely to influence gut function, colonic bacterial activity.
Who cannot join
- Antibiotics
- Pregnancy
- lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 6 Week Feeding Study of Interactions Between Fibre and Polyphenols Sources on Colonic Phenolic Acid Production and Biomarkers of Health
The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage \& onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human health, the gut microbiome, human proteome and markers of risk of chronic disease. This may allow better targeted evaluation of foods which influence health through the gut microbiome.
Read the detailed description
Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.
Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic health.
- Conditions
- Healthy
- Being tested
- Tomato, onion and lovage soup (TOL), TOL soup with inulin
- Keywords
- self-reported healthy adults, age 40-70, BMI > 25
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomato, onion and lovage soup (TOL)Other
Soup
TOL soup with inulinOther
Soup
| Study group | Role | What they receive |
|---|---|---|
| Habitual diet | No intervention | participants remain on their habitual diet |
| Tomato, onion and lovage soup (TOL) | Experimental | One tin of soup containing Tomato onion and lovage daily for 6 weeks Receives: Other: Tomato, onion and lovage soup (TOL) |
| TOL soup with inulin | Experimental | One tin of Tomato, onion and lovage soup with added inulin for 6 weeks Receives: Other: TOL soup with inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)
Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
Measured: 3 weeks
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)
Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
Measured: 6 weeks
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 start11 Jul 2018
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Model description
- This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Scottish Universities Environmental Research Centre
- Responsible party
- Principal investigator, Christine Edwards, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840746
- Sponsor's protocol ID
- BB/M027724/1-3
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2019
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Week Feeding Study of Interactions Between Fibre and Polyphenols Sources on Colonic Phenolic Acid Production and Biomarkers of Health
- ClinicalTrials.gov ID
- NCT03840746
- Acronym / sponsor ID
- BB/M027724/1-3
- Conditions
- Healthy
- Keywords
- self-reported healthy adults, age 40-70, BMI > 25
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Scottish Universities Environmental Research Centre
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (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.
The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage \& onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human health, the gut microbiome, human proteome and markers of risk of chronic disease. This may allow better targeted evaluation of foods which influence health through the gut microbiome.
Detailed description
Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.
Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)
| Arm | Type | Receives |
|---|---|---|
| Habitual diet | No intervention | –participants remain on their habitual diet |
| Tomato, onion and lovage soup (TOL) | Experimental | Other: Tomato, onion and lovage soup (TOL)One tin of soup containing Tomato onion and lovage daily for 6 weeks |
| TOL soup with inulin | Experimental | Other: TOL soup with inulinOne tin of Tomato, onion and lovage soup with added inulin for 6 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Generally healthy
- BMI>=25
- Not on antibiotics within 3 months of starting of study
- No medication likely to influence gut function, colonic bacterial activity.
Key exclusion criteria (3 listed)
- Antibiotics
- Pregnancy
- lactation
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 |
|---|---|---|
| Tomato, onion and lovage soup (TOL)Soup | Other | Tomato, onion and lovage soup (TOL) |
| TOL soup with inulinSoup | Other | TOL soup with inulin |
Primary outcome
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)
Time frame: 3 weeks
Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)
Time frame: 6 weeks
Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
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 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomato, onion and lovage soup (TOL) and TOL soup with inulin in people with Healthy, run by University of Glasgow 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 4 inclusion and 3 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 27 Mar 2023. 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 from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk) (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 27 Mar 2023.