Resistant Starch and Non-starch Polysaccharide (Dietary Fibre) Intake and the Colonic Microbiome in Older People

July 24, 2020 updated by: University of Dundee

Resistant Starch and Non-starch Polysaccharide (Dietary Fibre) Intake in Relation to the Structure and Metabolic Activities of the Colonic Microbiome in Older People

The development of preventative nutritional strategies to promote healthy ageing is becoming increasingly important. Elevated thresholds for taste and smell, coupled with swallowing difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets among the elderly. This can induce great changes in the composition and metabolic activities of the gut microbiome, leading to decreased intestinal motility and impaired bowel function. This can result in constipation or diarrhoea, increased basal levels of inflammation, immunosenescence and morbidity. The objectives of this study are to use dietary modification to improve gut health in older people. Diets high in resistant starch or dietary fibre will be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised double-blind cross-over study. The aim is to investigate the effects on microbiome composition and functionality through fermentation, reduced putrefaction, and modification of blood markers associated with obesity and diabetes.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United Kingdom
    • Tayside
      • Dundee, Tayside, United Kingdom, DD1 9SY
        • Division of Cardiovascular and Diabetes Medicine/Gastroenterology, Ninewells Hospital and Medical School

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

68 years to 93 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged 70-95 years, with BMI 18.5-30.0 kg m2.

Exclusion Criteria:

  • Exclusion criteria will include asplenia and other acquired or congenital immunodeficiencies
  • Any autoimmune disease
  • Self-reported symptoms of acute or recent infection (including use of antibiotics within the previous 3 months)
  • Taking probiotics or prebiotics, including lactulose for constipation
  • Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, cancer).
  • Specifically, volunteers who are diabetic will not be excluded from the investigation.
  • Assessment will be on a case by case basis.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistant starch (RS)
Resistant starch (RS3)
Dietary supplement: Resistant starch
Experimental: Dietary fibre
Dietary fibre (Arabinogalactan, gum guar, pectin)
Dietary supplement: Dietary fibre (arabinogalactan, gum guar, pectin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.
Time Frame: 4 weeks
4 weeks
Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked immunosorbent assay (ELISA).
Time Frame: 4 weeks
Measurement of cytokines Interleukin 6 (IL-6), Tumour necrosis factor-alpha (TNF-alpha), IL-1, IL-10, Interferon-gamma (INF-gamma), IL-4, IL-8, Monocyte chemoattractant protein 1( MCP-1) and serum C-reactive protein (CRP).
4 weeks
Number of participants with change in faecal genotoxic potential determined by measurement of faecal bacterial enzymes involved in the formation of genotoxic metabolites in the gut.
Time Frame: 4 weeks
Enzymes to be measured beta-glucosidase, beta-glucuronidase, azoreductase, nitroreductase
4 weeks
Number of participants with a change in bowel habit and quality of life measured by completion of a bowel habit diary and quality of life questionnaire.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

University of Dundee

Collaborators

Chief Scientist Office of the Scottish Government

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.

General Publications

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

May 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014GA05

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.

Clinical Trials on Aging

Clinical Trials on Resistant starch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe