AgingNCT02384174
Resistant Starch and Non-starch Polysaccharide (Dietary Fibre) Intake and the Colonic Microbiome in Older People
A study testing Resistant starch and Dietary fibre (arabinogalactan, gum guar, pectin) in people with Aging, run by University of Dundee at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 70 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistant starch and Dietary fibre (arabinogalactan, gum guar, pectin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged 70-95 years, with BMI 18.5-30.0 kg m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Cardiovascular and Diabetes Medicine/Gastroenterology, Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY
About this study
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
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
- Being tested
- Resistant starch, Dietary fibre (arabinogalactan, gum guar, pectin)
- Keywords
- Aging, Resistant starch, Dietary fibre, Immune system, Bacteria, older subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant starchDietary supplement
Dietary fibre (arabinogalactan, gum guar, pectin)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Resistant starch (RS) | Experimental | Resistant starch (RS3) Receives: Dietary Supplement: Resistant starch |
| Dietary fibre | Experimental | Dietary fibre (Arabinogalactan, gum guar, pectin) Receives: Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).
Measured: 4 weeks
Secondary outcomes (4)
Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384174
- Sponsor's protocol ID
- 2014GA05
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2015
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15466557Bartosch 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.
PubMed 15184159Macfarlane 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.
PubMed 23957631
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02384174
- Acronym / sponsor ID
- 2014GA05
- Conditions
- Aging
- Keywords
- Aging, Resistant starch, Dietary fibre, Immune system, Bacteria, older subjects
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant starch (RS) | Experimental | Dietary Supplement: Resistant starchResistant starch (RS3) |
| Dietary fibre | Experimental | Dietary Supplement: Dietary fibre (arabinogalactan, gum guar, pectin)Dietary fibre (Arabinogalactan, gum guar, pectin) |
Who may qualify
- Ages
- 70 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Men and women aged 70-95 years, with BMI 18.5-30.0 kg m2.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant starch | Dietary supplement | Resistant starch (RS) |
| Dietary fibre (arabinogalactan, gum guar, pectin) | Dietary supplement | Dietary fibre |
Primary outcome
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH).
Time frame: 4 weeks
4 secondary outcomes
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).
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 15466557Woodmansey 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.
- Background: PubMed 15184159Bartosch 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.
- Background: PubMed 23957631Macfarlane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant starch and Dietary fibre (arabinogalactan, gum guar, pectin) in people with Aging, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybridisation (FISH). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384174, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.