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

NCT ID: NCT02384174

Last Updated: 2020-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Resistant starch (RS)

Resistant starch (RS3)

Group Type EXPERIMENTAL

Resistant starch

Intervention Type DIETARY_SUPPLEMENT

Dietary fibre

Dietary fibre (Arabinogalactan, gum guar, pectin)

Group Type EXPERIMENTAL

Dietary fibre (arabinogalactan, gum guar, pectin)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Resistant starch

Intervention Type DIETARY_SUPPLEMENT

Dietary fibre (arabinogalactan, gum guar, pectin)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

70 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Cardiovascular and Diabetes Medicine/Gastroenterology, Ninewells Hospital and Medical School

Dundee, Tayside, United Kingdom

Site Status

Countries

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United Kingdom

References

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Woodmansey EJ, McMurdo ME, Macfarlane GT, Macfarlane S. Comparison of compositions and metabolic activities of fecal microbiotas in young adults and in antibiotic-treated and non-antibiotic-treated elderly subjects. Appl Environ Microbiol. 2004 Oct;70(10):6113-22. doi: 10.1128/AEM.70.10.6113-6122.2004.

Reference Type BACKGROUND
PMID: 15466557 (View on PubMed)

Bartosch S, Fite A, Macfarlane GT, McMurdo ME. Characterization of bacterial communities in feces from healthy elderly volunteers and hospitalized elderly patients by using real-time PCR and effects of antibiotic treatment on the fecal microbiota. Appl Environ Microbiol. 2004 Jun;70(6):3575-81. doi: 10.1128/AEM.70.6.3575-3581.2004.

Reference Type BACKGROUND
PMID: 15184159 (View on PubMed)

Macfarlane S, Cleary S, Bahrami B, Reynolds N, Macfarlane GT. Synbiotic consumption changes the metabolism and composition of the gut microbiota in older people and modifies inflammatory processes: a randomised, double-blind, placebo-controlled crossover study. Aliment Pharmacol Ther. 2013 Oct;38(7):804-16. doi: 10.1111/apt.12453. Epub 2013 Aug 20.

Reference Type BACKGROUND
PMID: 23957631 (View on PubMed)

Other Identifiers

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2014GA05

Identifier Type: -

Identifier Source: org_study_id

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