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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02384174
• Other study ID #: 2014GA05
• Status: Withdrawn
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: July 2020
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Resistant starch

• Dietary fibre (arabinogalactan, gum guar, pectin)

Locations

Country	Name	City	State
United Kingdom	Division of Cardiovascular and Diabetes Medicine/Gastroenterology, Ninewells Hospital and Medical School	Dundee	Tayside

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).		4 weeks
Secondary	Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.		4 weeks
Secondary	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).	4 weeks
Secondary	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	4 weeks
Secondary	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