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

Not Applicable
Withdrawn
Conditions
Aging
Interventions
Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)
Dietary Supplement: Resistant starch
Registration Number
NCT02384174
Lead Sponsor
University of Dundee
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Dietary fibreDietary fibre (arabinogalactan, gum guar, pectin)Dietary fibre (Arabinogalactan, gum guar, pectin)
Resistant starch (RS)Resistant starchResistant starch (RS3)
Primary Outcome Measures
NameTimeMethod
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).4 weeks
Secondary Outcome Measures
NameTimeMethod
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
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 weeks

Enzymes to be measured beta-glucosidase, beta-glucuronidase, azoreductase, nitroreductase

Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked immunosorbent assay (ELISA).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).

Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.4 weeks

Trial Locations

Locations (1)

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

🇬🇧

Dundee, Tayside, United Kingdom

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