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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03577145
Other study ID # BB/MO27724/1-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2017
Est. completion date December 31, 2018

Study information

Verified date January 2019
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tomato, onion & lovage soup with inulin
Source of polyphenols and non digestible carbohydrate
Tomato, onion & lovage soup
Source of polyphenols
Inulin
Source of non digestible carbohydrate

Locations

Country Name City State
United Kingdom School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow Glasgow Lanarkshire

Sponsors (2)

Lead Sponsor Collaborator
University of Glasgow Scottish Universities Environmental Research Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Phenolic acids bioavailability Urine excretion of phenolic acids (µg) will be measured with GC-MS 0-24 hrs
Secondary Glycaemic measurements Plasma glucose (mmol/L), insulin (mU/L) will be measured by commercial kits 0-8 hrs
Secondary Appetite hormones measurements Appetite hormone (PYY) levels in plasma (pg/mL) will be measured by commercial Elisa kit 0-8 hrs
Secondary 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 0-8 hrs
Secondary Gastric emptying time Gastric emptying time (in hours/mins) will be estimated using kinetics of plasma paracetamol levels measured by acetaminophen assay kits 0-6 hrs
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