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

Sponsor

University of Dundee (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02384174

Collaborator

Chief Scientist Office of the Scottish Government (Other)

Enrollment

Location

Arms

21.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Dietary Supplement: Resistant starch Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resistant starch (RS) Resistant starch (RS3)	Dietary Supplement: Resistant starch
Experimental: Dietary fibre Dietary fibre (Arabinogalactan, gum guar, pectin)	Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)

Arm

Intervention/Treatment

Experimental: Resistant starch (RS)

Resistant starch (RS3)

Dietary Supplement: Resistant starch

Experimental: Dietary fibre

Dietary fibre (Arabinogalactan, gum guar, pectin)

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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 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 a change in bowel habit and quality of life measured by completion of a bowel habit diary and quality of life questionnaire. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.