- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577145
Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lanarkshire
-
Glasgow, Lanarkshire, United Kingdom, G31 2ER
- School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Self-reported healthy adults
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tomato, onion & lovage soup with inulin
One dose of tomato (300g), onion (100g) & lovage (20g) with 10g inulin will be given to subjects in the form of a soup
|
Source of polyphenols and non digestible carbohydrate
|
EXPERIMENTAL: Tomato, onion & lovage soup
One dose of tomato (300g), onion (100g) & lovage (20g) will be given to subjects in the form of a soup
|
Source of polyphenols
|
EXPERIMENTAL: Inulin
One dose of 10g inulin will be given to subjects in the form of a drink
|
Source of non digestible carbohydrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenolic acids bioavailability
Time Frame: 0-24 hrs
|
Urine excretion of phenolic acids (µg) will be measured with GC-MS
|
0-24 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycaemic measurements
Time Frame: 0-8 hrs
|
Plasma glucose (mmol/L), insulin (mU/L) will be measured by commercial kits
|
0-8 hrs
|
Appetite hormones measurements
Time Frame: 0-8 hrs
|
Appetite hormone (PYY) levels in plasma (pg/mL) will be measured by commercial Elisa kit
|
0-8 hrs
|
Mouth to caecum transit time
Time Frame: 0-8 hrs
|
Mouth to caecum transit time (in hours/mins) will be calculated from sustained rise in breath hydrogen level measurements by hydrogen monitor
|
0-8 hrs
|
Gastric emptying time
Time Frame: 0-6 hrs
|
Gastric emptying time (in hours/mins) will be estimated using kinetics of plasma paracetamol levels measured by acetaminophen assay kits
|
0-6 hrs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Edwards, PhD, University of Glasgow
Publications and helpful links
General 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.
- Roowi 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.
- Tamura 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BB/MO27724/1-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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