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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02384174
Enrollment
0
Registered
2015-03-10
Start date
2015-05-31
Completion date
2017-02-01
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Aging, Resistant starch, Dietary fibre, Immune system, Bacteria, older subjects

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTResistant starch
DIETARY_SUPPLEMENTDietary fibre (arabinogalactan, gum guar, pectin)

Sponsors

Chief Scientist Office of the Scottish Government
CollaboratorOTHER_GOV
University of Dundee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
70 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).4 weeks

Secondary

MeasureTime frameDescription
Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.4 weeks
Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked immunosorbent assay (ELISA).4 weeksMeasurement 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).
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.4 weeksEnzymes to be measured beta-glucosidase, beta-glucuronidase, azoreductase, nitroreductase
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.4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026