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Completed

NCT Number: 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.

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow

Glasgow, Lanarkshire, G31 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tomato, onion & lovage soup with inulin

Dietary Supplement

Source of polyphenols and non digestible carbohydrate

Tomato, onion & lovage soup

Dietary Supplement

Source of polyphenols

Inulin

Dietary Supplement

Source of non digestible carbohydrate

Primary outcomes

  1. Phenolic acids bioavailability

    Time frame: 0-24 hrs

    Urine excretion of phenolic acids (µg) will be measured with GC-MS

Secondary outcomes

  1. Glycaemic measurements

    Time frame: 0-8 hrs

    Plasma glucose (mmol/L), insulin (mU/L) will be measured by commercial kits

  2. Appetite hormones measurements

    Time frame: 0-8 hrs

    Appetite hormone (PYY) levels in plasma (pg/mL) will be measured by commercial Elisa kit

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Scottish Universities Environmental Research Centre

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2018
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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