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

NCT02384174 | Withdrawn DMC

• 1 other identifier: 2014GA05
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).

  4 weeks

Secondary Outcomes (4)

• 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 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

• 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

Study Arms (2)

Resistant starch (RS)

EXPERIMENTAL

Resistant starch (RS3)

Dietary Supplement: Resistant starch

Dietary fibre

EXPERIMENTAL

Dietary fibre (Arabinogalactan, gum guar, pectin)

Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)

Interventions

Resistant starch DIETARY_SUPPLEMENT

Resistant starch (RS)

Dietary fibre (arabinogalactan, gum guar, pectin) DIETARY_SUPPLEMENT

Dietary fibre

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dundee: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

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

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 15466557 BACKGROUND

• 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.

  PMID: 15184159 BACKGROUND

• 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.

  PMID: 23957631 BACKGROUND

MeSH Terms

Interventions

Resistant Starch; Dietary Fiber; arabinogalactan; guar gum; Pectins

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 10, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

GB (1)