HypercholesterolemiaFFSNCT02693782
Fabulous Fibre Study - Effect of Wheat Bran Extract on Gut and General Health in Healthy Aging Subjects (FFS)
A study testing Fibre supplement in people with Hypercholesterolemia and Flatulence, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This is a placebo controlled, cross-over, randomized, double blinded study. The intervention food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day). 2. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Flatulence, Intestinal Diseases
- What is being tested?
- Fibre supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Feb 2016
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 60 years and above
- Body mass index 20-32 kg/m2
Who cannot join
- Fructose intolerance/ or any of the ingredients in the prebiotic mix
- On prescription antibiotics within the past 3 months
- Bowel disorder
- Vegetarian or vegan
- Eating disorders and food intolerances (restricted eating)
- Wheat and gluten allergy, coeliac disease
Show all 11Show fewer
- Alcohol and/or other substance abuse
- Regular intake of prebiotic or probiotic supplements
- Smoking
- Psychiatric disorders resulting in perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
- Lipid/Cholesterol lowering medication (as cholesterol is one of the endpoints of the study)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, AB21 9SB
About this study
Official title: Effect of Wheat Bran Extract Containing Arabinoxylan Oligosaccharides, on the Gut Microbiota Composition and Well-being in Healthy Aging Subjects PhD Project: New Targeted Prebiotic Approaches for Maintaining Human Health
This is a placebo controlled, cross-over, randomized, double blinded study. The intervention food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day). 2. Placebo product maltodextrin:equal amounts of a digestible carbohydrate.
Primary endpoints are faecal microbiota analysis and faecal metabolite analysis (particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose, HDL and bowel function, gastrointestinal tolerance, quality of life and food frequency (by the use of questionnaires).
Read the detailed description
Participants will be identified and recruited at the HNU and RIHN. Participants will be informed about the study aims and procedures and will be pre-screened on the basis of inclusion/exclusion criteria. If eligible, they will sign the informed consent and enter the study with visit 0 where a clinical and biochemical evaluation of the health status will be performed. If subjects are still eligible for the study according to all the exclusion criteria, they will be included into the trial and randomised to receive the active supplementation or placebo at visit 1 (day 5). Volunteers will be invited to commence the study in batches of 5 people.
Following 5 days of maintenance diet (their usual diet), on visit 1 (day 5) volunteers would bring their fresh faecal sample to HNU, blood sample and blood pressure measurement will be taken during their visit. The placebo or fibre supplements will be given to them, enough for the next 5 days. On visit 2 (day 10), volunteers would come to HNU to deliver their faecal sample and the next 5 days' worth of placebo or fibre supplements will be provided. Volunteers will return to HNU for visit 3 (day 15) to deliver their faecal sample, blood sample and blood pressure measurement will be taken on site. There will be a wash out period of 5 days with no study product provided to the volunteers. On visit 4 (day 20), the study intervention would then cross-over and the volunteers will deliver their faecal sample to HNU. Blood sample and blood pressure measurement will be taken and the volunteers will be given the next set of products, enough for the next 5 days. On visit 5 (day 25), volunteers would come to HNU to deliver their faecal sample and the next 5 days' worth of placebo or fibre supplement will be given to them. At the end of the second intervention (day 30), volunteers will come in for visit 6 to deliver their faecal sample and have blood sample and blood pressure measurement taken.
The study will end with 5 days of wash out period, where volunteers consume their own usual diet. Volunteers would come to HNU for a final visit 7 (day 35), faecal sample will be collected at the end of the wash out period.
- Conditions
- Hypercholesterolemia, Flatulence, Intestinal Diseases
- Being tested
- Placebo, Fibre supplement
- Keywords
- Fibre, Wheat Bran Extract, Microbiota, Microbiota metabolites, Gastrointestinal tolerance
- Medical subject headings
- Hypercholesterolemia, Flatulence, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
15 g/day maltodextrin in 3 portions of 5 g.
Fibre supplementDietary supplement
15 g/day Wheat Bran Extract in 3 portions of 5 g.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 15 g/day maltodextrin in 3 portions of 5 g. Receives: Dietary Supplement: Placebo |
| Fibre supplement | Active comparator | 15 g/day Wheat Bran Extract in 3 portions of 5 g. Receives: Dietary Supplement: Fibre supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the gut microbiota metabolites
Samples will be used for metabolite analysis using short chain fatty acid analysis.
Measured: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Secondary outcomes (10)
Changes in the gut microbiota
Sample will be used for microbiota analysis using molecular methods such as high-throughput sequencing and qPCR.
Measured: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Changes in blood glucose
Blood samples will be measured for glucose using the Cholestech method.
Measured: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood HDL
Blood samples will be measured for HDL using the Cholestech method.
Measured: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood LDL
Blood samples will be measured for LDL using the Cholestech method.
Measured: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood triglycerides
Blood samples will be measured for triglycerides using the Cholestech method.
Measured: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood cholesterol
Blood samples will be measured for cholesterol using the Cholestech method.
Measured: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Gastrointestinal tolerance
A daily questionnaire will be asked on:
- Nausea
- Bloating
- Flatulence
- Cramps
- Bowel movements
- Stool appearance
Measured: This is assessed via a daily questionnaire throughout the whole study period of 35 days.
Volunteer's habitual diet food intake
A Food Frequency Questionnaire (FFQ) will be completed at the start and the end of the study. http://www.foodfrequency.org/
Measured: This is assessed via questionnaires given at the start and end of the study (day 0 and day 35)
General health and well-being (This is assessed via questionnaires at the end of the study)
A health survey will be completed at the end of the study on activities, physical and emotional well-being.
Measured: day 35
Changes in faecal inflammatory markers
Faecal calprotectin will be measured using ELISA method.
Measured: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Harry J Flint, Professor, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693782
- Sponsor's protocol ID
- 15/HSMC/004
- Acronym
- FFS
- Status last verified
- Sep 2016
- First submitted
- 29 Jun 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
PubMed 22797518Cloetens L, Broekaert WF, Delaedt Y, Ollevier F, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Tolerance of arabinoxylan-oligosaccharides and their prebiotic activity in healthy subjects: a randomised, placebo-controlled cross-over study. Br J Nutr. 2010 Mar;103(5):703-13. doi: 10.1017/S0007114509992248. Epub 2009 Dec 10.
PubMed 20003568Duncan SH, Hold GL, Harmsen HJM, Stewart CS, Flint HJ. Growth requirements and fermentation products of Fusobacterium prausnitzii, and a proposal to reclassify it as Faecalibacterium prausnitzii gen. nov., comb. nov. Int J Syst Evol Microbiol. 2002 Nov;52(Pt 6):2141-2146. doi: 10.1099/00207713-52-6-2141.
PubMed 12508881Duncan SH, Flint HJ. Probiotics and prebiotics and health in ageing populations. Maturitas. 2013 May;75(1):44-50. doi: 10.1016/j.maturitas.2013.02.004. Epub 2013 Mar 11.
PubMed 23489554Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012 Sep 4;9(10):577-89. doi: 10.1038/nrgastro.2012.156. eCollection 2012 Oct.
PubMed 22945443Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Evenepoel P, Hamer H, Houben E, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of a wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal health parameters in healthy adult human volunteers: a double-blind, randomised, placebo-controlled, cross-over trial. Br J Nutr. 2012 Dec 28;108(12):2229-42. doi: 10.1017/S0007114512000372. Epub 2012 Feb 28.
PubMed 22370444Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.
PubMed 24368315Hopkins MJ, Sharp R, Macfarlane GT. Age and disease related changes in intestinal bacterial populations assessed by cell culture, 16S rRNA abundance, and community cellular fatty acid profiles. Gut. 2001 Feb;48(2):198-205. doi: 10.1136/gut.48.2.198.
PubMed 11156640Lewis SJ, Heaton KW. Increasing butyrate concentration in the distal colon by accelerating intestinal transit. Gut. 1997 Aug;41(2):245-51. doi: 10.1136/gut.41.2.245.
PubMed 9301506Maki KC, Gibson GR, Dickmann RS, Kendall CW, Chen CY, Costabile A, Comelli EM, McKay DL, Almeida NG, Jenkins D, Zello GA, Blumberg JB. Digestive and physiologic effects of a wheat bran extract, arabino-xylan-oligosaccharide, in breakfast cereal. Nutrition. 2012 Nov-Dec;28(11-12):1115-21. doi: 10.1016/j.nut.2012.02.010. Epub 2012 Jul 6.
PubMed 22771050Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208.
PubMed 21677746Parracho H, McCartney AL, Gibson GR. Probiotics and prebiotics in infant nutrition. Proc Nutr Soc. 2007 Aug;66(3):405-11. doi: 10.1017/S0029665107005678.
PubMed 17637093Pryde SE, Duncan SH, Hold GL, Stewart CS, Flint HJ. The microbiology of butyrate formation in the human colon. FEMS Microbiol Lett. 2002 Dec 17;217(2):133-9. doi: 10.1111/j.1574-6968.2002.tb11467.x.
PubMed 12480096Rastall RA, Maitin V. Prebiotics and synbiotics: towards the next generation. Curr Opin Biotechnol. 2002 Oct;13(5):490-6. doi: 10.1016/s0958-1669(02)00365-8.
PubMed 12459343Scott KP, Gratz SW, Sheridan PO, Flint HJ, Duncan SH. The influence of diet on the gut microbiota. Pharmacol Res. 2013 Mar;69(1):52-60. doi: 10.1016/j.phrs.2012.10.020. Epub 2012 Nov 9.
PubMed 23147033
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wheat Bran Extract Containing Arabinoxylan Oligosaccharides, on the Gut Microbiota Composition and Well-being in Healthy Aging Subjects PhD Project: New Targeted Prebiotic Approaches for Maintaining Human Health
- ClinicalTrials.gov ID
- NCT02693782
- Acronym / sponsor ID
- FFS / 15/HSMC/004
- Conditions
- Hypercholesterolemia, Flatulence, Intestinal Diseases
- Keywords
- Fibre, Wheat Bran Extract, Microbiota, Microbiota metabolites, Gastrointestinal tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Feb 2016 (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.
This is a placebo controlled, cross-over, randomized, double blinded study. The intervention food products will be taken as diet prebiotic supplements: 1. Wheat Bran Extract rich in arabinoxylan oligosaccharides : 15g/d (up to 10 g total additional dietary fibre per day). 2. Placebo product maltodextrin:equal amounts of a digestible carbohydrate.
Primary endpoints are faecal microbiota analysis and faecal metabolite analysis (particularly, short chain fatty acid). Secondary endpoint is serum cholesterol, glucose, HDL and bowel function, gastrointestinal tolerance, quality of life and food frequency (by the use of questionnaires).
Detailed description
Participants will be identified and recruited at the HNU and RIHN. Participants will be informed about the study aims and procedures and will be pre-screened on the basis of inclusion/exclusion criteria. If eligible, they will sign the informed consent and enter the study with visit 0 where a clinical and biochemical evaluation of the health status will be performed. If subjects are still eligible for the study according to all the exclusion criteria, they will be included into the trial and randomised to receive the active supplementation or placebo at visit 1 (day 5). Volunteers will be invited to commence the study in batches of 5 people.
Following 5 days of maintenance diet (their usual diet), on visit 1 (day 5) volunteers would bring their fresh faecal sample to HNU, blood sample and blood pressure measurement will be taken during their visit. The placebo or fibre supplements will be given to them, enough for the next 5 days. On visit 2 (day 10), volunteers would come to HNU to deliver their faecal sample and the next 5 days' worth of placebo or fibre supplements will be provided. Volunteers will return to HNU for visit 3 (day 15) to deliver their faecal sample, blood sample and blood pressure measurement will be taken on site. There will be a wash out period of 5 days with no study product provided to the volunteers. On visit 4 (day 20), the study intervention would then cross-over and the volunteers will deliver their faecal sample to HNU. Blood sample and blood pressure measurement will be taken and the volunteers will be given the next set of products, enough for the next 5 days. On visit 5 (day 25), volunteers would come to HNU to deliver their faecal sample and the next 5 days' worth of placebo or fibre supplement will be given to them. At the end of the second intervention (day 30), volunteers will come in for visit 6 to deliver their faecal sample and have blood sample and blood pressure measurement taken.
The study will end with 5 days of wash out period, where volunteers consume their own usual diet. Volunteers would come to HNU for a final visit 7 (day 35), faecal sample will be collected at the end of the wash out period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo15 g/day maltodextrin in 3 portions of 5 g. |
| Fibre supplement | Active comparator | Dietary Supplement: Fibre supplement15 g/day Wheat Bran Extract in 3 portions of 5 g. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 60 years and above
- Body mass index 20-32 kg/m2
Key exclusion criteria (11 listed)
- Fructose intolerance/ or any of the ingredients in the prebiotic mix
- On prescription antibiotics within the past 3 months
- Bowel disorder
- Vegetarian or vegan
- Eating disorders and food intolerances (restricted eating)
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 |
|---|---|---|
| Placebo15 g/day maltodextrin in 3 portions of 5 g. | Dietary supplement | Placebo |
| Fibre supplement15 g/day Wheat Bran Extract in 3 portions of 5 g. | Dietary supplement | Fibre supplement |
Primary outcome
Changes in the gut microbiota metabolites
Time frame: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Samples will be used for metabolite analysis using short chain fatty acid analysis.
10 secondary outcomes
Changes in the gut microbiota
Time frame: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Changes in blood glucose
Time frame: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood HDL
Time frame: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood LDL
Time frame: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood triglycerides
Time frame: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Changes in blood cholesterol
Time frame: Blood samples collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days
Gastrointestinal tolerance
Time frame: This is assessed via a daily questionnaire throughout the whole study period of 35 days.
Volunteer's habitual diet food intake
Time frame: This is assessed via questionnaires given at the start and end of the study (day 0 and day 35)
General health and well-being (This is assessed via questionnaires at the end of the study)
Time frame: day 35
Changes in faecal inflammatory markers
Time frame: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Background: PubMed 22797518Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
- Background: PubMed 20003568Cloetens L, Broekaert WF, Delaedt Y, Ollevier F, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Tolerance of arabinoxylan-oligosaccharides and their prebiotic activity in healthy subjects: a randomised, placebo-controlled cross-over study. Br J Nutr. 2010 Mar;103(5):703-13. doi: 10.1017/S0007114509992248. Epub 2009 Dec 10.
- Background: PubMed 12508881Duncan SH, Hold GL, Harmsen HJM, Stewart CS, Flint HJ. Growth requirements and fermentation products of Fusobacterium prausnitzii, and a proposal to reclassify it as Faecalibacterium prausnitzii gen. nov., comb. nov. Int J Syst Evol Microbiol. 2002 Nov;52(Pt 6):2141-2146. doi: 10.1099/00207713-52-6-2141.
- Background: PubMed 23489554Duncan SH, Flint HJ. Probiotics and prebiotics and health in ageing populations. Maturitas. 2013 May;75(1):44-50. doi: 10.1016/j.maturitas.2013.02.004. Epub 2013 Mar 11.
- Background: PubMed 22945443Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012 Sep 4;9(10):577-89. doi: 10.1038/nrgastro.2012.156. eCollection 2012 Oct.
- Background: PubMed 22370444Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Evenepoel P, Hamer H, Houben E, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of a wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal health parameters in healthy adult human volunteers: a double-blind, randomised, placebo-controlled, cross-over trial. Br J Nutr. 2012 Dec 28;108(12):2229-42. doi: 10.1017/S0007114512000372. Epub 2012 Feb 28.
- Background: PubMed 24368315Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.
- Background: PubMed 11156640Hopkins MJ, Sharp R, Macfarlane GT. Age and disease related changes in intestinal bacterial populations assessed by cell culture, 16S rRNA abundance, and community cellular fatty acid profiles. Gut. 2001 Feb;48(2):198-205. doi: 10.1136/gut.48.2.198.
- Background: PubMed 9301506Lewis SJ, Heaton KW. Increasing butyrate concentration in the distal colon by accelerating intestinal transit. Gut. 1997 Aug;41(2):245-51. doi: 10.1136/gut.41.2.245.
- Background: PubMed 22771050Maki KC, Gibson GR, Dickmann RS, Kendall CW, Chen CY, Costabile A, Comelli EM, McKay DL, Almeida NG, Jenkins D, Zello GA, Blumberg JB. Digestive and physiologic effects of a wheat bran extract, arabino-xylan-oligosaccharide, in breakfast cereal. Nutrition. 2012 Nov-Dec;28(11-12):1115-21. doi: 10.1016/j.nut.2012.02.010. Epub 2012 Jul 6.
- Background: PubMed 21677746Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208.
- Background: PubMed 17637093Parracho H, McCartney AL, Gibson GR. Probiotics and prebiotics in infant nutrition. Proc Nutr Soc. 2007 Aug;66(3):405-11. doi: 10.1017/S0029665107005678.
- Individual participant dataSharing planned: No
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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.
Harry J Flint, Professor principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre supplement in people with Hypercholesterolemia and Flatulence, run by University of Aberdeen 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 2 May 2017. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the gut microbiota metabolites (time frame: Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days). 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 NCT02693782, which also lists 20 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 2 May 2017.