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Trial record 18 of 29 for:    GUSB

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

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ClinicalTrials.gov Identifier: NCT02384174
Recruitment Status : Withdrawn
First Posted : March 10, 2015
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Resistant starch Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 2015
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Starch

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)



Primary Outcome Measures :
  1. Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH). [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH. [ Time Frame: 4 weeks ]
  2. Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked immunosorbent assay (ELISA). [ Time Frame: 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).

  3. 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. [ Time Frame: 4 weeks ]
    Enzymes to be measured beta-glucosidase, beta-glucuronidase, azoreductase, nitroreductase

  4. 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 ]


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Ages Eligible for Study:   70 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384174


Locations
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United Kingdom
Division of Cardiovascular and Diabetes Medicine/Gastroenterology, Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government