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Completed

NCT Number: NCT03383809

Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. We hypothesize that combination of dietary polyphenolics and non-digestible carbohydrates (NDC) 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 randomised order: Strawberry juice (a high polyphenol food), Inulin (NDC) or Mixture of strawberry juice and inulin.

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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. The colonic microbiota are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as dietary fibre to short chain fatty acids. It is likely that there are key interactions in the colonic bacteria metabolism of fibre and phenolics. We hypothesize that combination of polyphenolics and non-digestible carbohydrates (NDC) will increase the urinary output of bioactive phenolic acids.

This study will enable a better understanding of how to deliver combinations of ingredients and nutrients to achieve maximum nutritional value and health benefits.

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, individuals who are pregnant or breastfeeding. Individuals who have been diagnosed as anaemic, as well as those who are allergic to any food, or paracetamol.

Treatment and study plan

Strawberry juice with Inulin

Dietary Supplement

Mixture of polyphenols and non digestible carbohydrates

Strawberry Juice

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

Secondary outcomes

  1. Urolithin bioavailability

    Time frame: 0-24 hrs

    Urine excretion of urolithins

  2. Glycaemic and appetite hormones measurements by ELISA

    Time frame: 0-8 hrs

    Plasma glucose, insulin and appetite hormone levels

  3. Mouth to caecum transit time

    Time frame: 0-8 hrs

    Breath hydrogen level measurements by Hydrogen monitor

  4. Gastric emptying time

    Time frame: 0-6 hrs

    Plasma paracetamol levels 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
2019
Study completion
2019
First posted
Dec 26, 2017
Registry last updated
Jul 12, 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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