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

July 11, 2019 updated by: Christine Edwards, University of Glasgow
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.

Study Overview

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. 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G31 2ER
        • School of Medicine, Nursing and Dentistry, College of MVLS, University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strawberry juice with inulin
One dose of 300 g of strawberry with 10 g of inulin will be given to subjects in the form of juice
Mixture of polyphenols and non digestible carbohydrates
Experimental: Strawberry juice
One dose of 300 g of strawberry juice will be given to subjects in the form of juice
Source of Polyphenols
Experimental: Inulin
One dose of 10 g of 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
0-24 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urolithin bioavailability
Time Frame: 0-24 hrs
Urine excretion of urolithins
0-24 hrs
Glycaemic and appetite hormones measurements by ELISA
Time Frame: 0-8 hrs
Plasma glucose, insulin and appetite hormone levels
0-8 hrs
Mouth to caecum transit time
Time Frame: 0-8 hrs
Breath hydrogen level measurements by Hydrogen monitor
0-8 hrs
Gastric emptying time
Time Frame: 0-6 hrs
Plasma paracetamol levels by acetaminophen assay kits
0-6 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Prof. Edwards, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2017

Primary Completion (Actual)

July 6, 2019

Study Completion (Actual)

July 6, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BB/MO27724/1-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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