An interventional study of Resistant starch and Dietary fibre (arabinogalactan, gum guar, pectin) in Aging, sponsored by University of Dundee. Withdrawn at 1 site in United Kingdom. Open to participants aged 70 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by University of Dundee · Not applicable, Interventional, and Prevention
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.
University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Resistant starch (RS3)
Dietary Supplement: Resistant starch
Dietary fibre (Arabinogalactan, gum guar, pectin)
Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).
Time frame: 4 weeks
Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.
Time frame: 4 weeks
Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked immunosorbent assay (ELISA).
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).
Time frame: 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.
Enzymes to be measured beta-glucosidase, beta-glucuronidase, azoreductase, nitroreductase
Time frame: 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
This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Dundee