Healthy AdultsNCT03577145
Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup
A study testing Tomato, onion & lovage soup with inulin, Tomato, onion & lovage soup and Inulin in people with Healthy Adults, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Tomato, onion & lovage soup with inulin, Tomato, onion & lovage soup and Inulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jul 2017to 31 Dec 2018
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported healthy adults
Who cannot join
- Antibiotic use within the last 3 months
- Identified gastro-intestinal diseases
- On prescribed medication other than the contraceptive pill
- Pregnant or breastfeeding.
- Diagnosed as anaemic
- Allergic to paracetamol or any food
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow
Glasgow, Lanarkshire, G31 2ER
About this study
This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomized order: Tomato, onion and lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup and inulin.
During each feeding study, urine, blood and stool samples will be collected at regular intervals for the duration of 24 hrs after consumption of test food. Participants will be asked to follow a low polyphenol diet for 2 days prior to the feeding study.
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.
- Conditions
- Healthy Adults
- Being tested
- Tomato, onion & lovage soup with inulin, Tomato, onion & lovage soup, Inulin
- Keywords
- Bioavailability, Polyphenols, Dietary fibre, Phenolic acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomato, onion & lovage soup with inulinDietary supplement
Source of polyphenols and non digestible carbohydrate
Tomato, onion & lovage soupDietary supplement
Source of polyphenols
InulinDietary supplement
Source of non digestible carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Tomato, onion & lovage soup with inulin | Experimental | One dose of tomato (300g), onion (100g) \& lovage (20g) with 10g inulin will be given to subjects in the form of a soup Receives: Dietary Supplement: Tomato, onion & lovage soup with inulin |
| Tomato, onion & lovage soup | Experimental | One dose of tomato (300g), onion (100g) \& lovage (20g) will be given to subjects in the form of a soup Receives: Dietary Supplement: Tomato, onion & lovage soup |
| Inulin | Experimental | One dose of 10g inulin will be given to subjects in the form of a drink Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenolic acids bioavailability
Urine excretion of phenolic acids (µg) will be measured with GC-MS
Measured: 0-24 hrs
Secondary outcomes (4)
Glycaemic measurements
Plasma glucose (mmol/L), insulin (mU/L) will be measured by commercial kits
Measured: 0-8 hrs
Appetite hormones measurements
Appetite hormone (PYY) levels in plasma (pg/mL) will be measured by commercial Elisa kit
Measured: 0-8 hrs
Mouth to caecum transit time
Mouth to caecum transit time (in hours/mins) will be calculated from sustained rise in breath hydrogen level measurements by hydrogen monitor
Measured: 0-8 hrs
Gastric emptying time
Gastric emptying time (in hours/mins) will be estimated using kinetics of plasma paracetamol levels measured by acetaminophen assay kits
Measured: 0-6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start27 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Acute human bioavailability studies with a cross-over design. Subjects will be given a soup or drink in one of three combinations 1. Tomato onion and lovage soup 2. Inulin 3. Mixture of tomato onion and lovage soup with inulin
- Masking
- None (open label)
- Enrolment
- 15 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
- Investigators
- Christine Edwards, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577145
- Sponsor's protocol ID
- BB/MO27724/1-2
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2017
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Russell W, Duthie G. Plant secondary metabolites and gut health: the case for phenolic acids. Proc Nutr Soc. 2011 Aug;70(3):389-96. doi: 10.1017/S0029665111000152.
PubMed 21781364Roowi S, Mullen W, Edwards CA, Crozier A. Yoghurt impacts on the excretion of phenolic acids derived from colonic breakdown of orange juice flavanones in humans. Mol Nutr Food Res. 2009 May;53 Suppl 1:S68-75. doi: 10.1002/mnfr.200800287.
PubMed 19415668Tamura M, Nakagawa H, Tsushida T, Hirayama K, Itoh K. Effect of pectin enhancement on plasma quercetin and fecal flora in rutin-supplemented mice. J Food Sci. 2007 Nov;72(9):S648-51. doi: 10.1111/j.1750-3841.2007.00557.x.
PubMed 18034749
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup
- ClinicalTrials.gov ID
- NCT03577145
- Acronym / sponsor ID
- BB/MO27724/1-2
- Conditions
- Healthy Adults
- Keywords
- Bioavailability, Polyphenols, Dietary fibre, Phenolic acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Scottish Universities Environmental Research Centre
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jul 2018 (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 is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomized order: Tomato, onion and lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup and inulin.
During each feeding study, urine, blood and stool samples will be collected at regular intervals for the duration of 24 hrs after consumption of test food. Participants will be asked to follow a low polyphenol diet for 2 days prior to the feeding study.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Acute human bioavailability studies with a cross-over design. Subjects will be given a soup or drink in one of three combinations 1. Tomato onion and lovage soup 2. Inulin 3. Mixture of tomato onion and lovage soup with inulin
| Arm | Type | Receives |
|---|---|---|
| Tomato, onion & lovage soup with inulin | Experimental | Dietary Supplement: Tomato, onion & lovage soup with inulinOne dose of tomato (300g), onion (100g) \& lovage (20g) with 10g inulin will be given to subjects in the form of a soup |
| Tomato, onion & lovage soup | Experimental | Dietary Supplement: Tomato, onion & lovage soupOne dose of tomato (300g), onion (100g) \& lovage (20g) will be given to subjects in the form of a soup |
| Inulin | Experimental | Dietary Supplement: InulinOne dose of 10g inulin will be given to subjects in the form of a drink |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported healthy adults
Key exclusion criteria (6 listed)
- Antibiotic use within the last 3 months
- Identified gastro-intestinal diseases
- On prescribed medication other than the contraceptive pill
- Pregnant or breastfeeding.
- Diagnosed as anaemic
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 & lovage soup with inulinSource of polyphenols and non digestible carbohydrate | Dietary supplement | Tomato, onion & lovage soup with inulin |
| Tomato, onion & lovage soupSource of polyphenols | Dietary supplement | Tomato, onion & lovage soup |
| InulinSource of non digestible carbohydrate | Dietary supplement | Inulin |
Primary outcome
Phenolic acids bioavailability
Time frame: 0-24 hrs
Urine excretion of phenolic acids (µg) will be measured with GC-MS
4 secondary outcomes
Glycaemic measurements
Time frame: 0-8 hrs
Appetite hormones measurements
Time frame: 0-8 hrs
Mouth to caecum transit time
Time frame: 0-8 hrs
Gastric emptying time
Time frame: 0-6 hrs
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 18 Jan 2019.
- Background: PubMed 21781364Russell W, Duthie G. Plant secondary metabolites and gut health: the case for phenolic acids. Proc Nutr Soc. 2011 Aug;70(3):389-96. doi: 10.1017/S0029665111000152.
- Background: PubMed 19415668Roowi S, Mullen W, Edwards CA, Crozier A. Yoghurt impacts on the excretion of phenolic acids derived from colonic breakdown of orange juice flavanones in humans. Mol Nutr Food Res. 2009 May;53 Suppl 1:S68-75. doi: 10.1002/mnfr.200800287.
- Background: PubMed 18034749Tamura M, Nakagawa H, Tsushida T, Hirayama K, Itoh K. Effect of pectin enhancement on plasma quercetin and fecal flora in rutin-supplemented mice. J Food Sci. 2007 Nov;72(9):S648-51. doi: 10.1111/j.1750-3841.2007.00557.x.
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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.
Christine Edwards, PhD principal investigator
University of Glasgow
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 & lovage soup with inulin, Tomato, onion & lovage soup and Inulin in people with Healthy Adults, 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 1 inclusion and 6 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 18 Jan 2019. 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?
Phenolic acids bioavailability (time frame: 0-24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577145, which also lists 3 linked publications.
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 18 Jan 2019.