NCT02693782

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
Last Updated

May 2, 2017

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

June 29, 2015

Last Update Submit

May 1, 2017

Conditions

HypercholesterolemiaFlatulenceIntestinal Diseases

Keywords

FibreWheat Bran ExtractMicrobiotaMicrobiota metabolitesGastrointestinal tolerance

Outcome Measures

Primary Outcomes (1)

  • Changes in the gut microbiota metabolites

    Samples will be used for metabolite analysis using short chain fatty acid analysis.

    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

    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 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 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 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 collected on test visit 1, 3, 4, 6 (day 5, 15, 20, 30) over an expected period of 35 days

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

15 g/day maltodextrin in 3 portions of 5 g.

Dietary Supplement: Placebo

Fibre supplement

ACTIVE COMPARATOR

15 g/day Wheat Bran Extract in 3 portions of 5 g.

Dietary Supplement: Fibre supplement

Interventions

PlaceboDIETARY_SUPPLEMENT

15 g/day maltodextrin in 3 portions of 5 g.

Placebo
Fibre supplementDIETARY_SUPPLEMENT

15 g/day Wheat Bran Extract in 3 portions of 5 g.

Fibre supplement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 60 years and above
  • Body mass index 20-32 kg/m2

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, AB21 9SB, United Kingdom

Location

Related Publications (20)

  • 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.

    PMID: 22797518BACKGROUND

  • Cloetens 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.

    PMID: 20003568BACKGROUND

  • Duncan 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.

    PMID: 12508881BACKGROUND

  • Duncan 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.

    PMID: 23489554BACKGROUND

  • Flint 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.

    PMID: 22945443BACKGROUND

  • Francois 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.

    PMID: 22370444BACKGROUND

  • Francois 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.

    PMID: 24368315BACKGROUND

  • Hopkins 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.

    PMID: 11156640BACKGROUND

  • Lewis 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.

    PMID: 9301506BACKGROUND

  • Maki 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.

    PMID: 22771050BACKGROUND

  • Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208.

    PMID: 21677746BACKGROUND

  • Parracho H, McCartney AL, Gibson GR. Probiotics and prebiotics in infant nutrition. Proc Nutr Soc. 2007 Aug;66(3):405-11. doi: 10.1017/S0029665107005678.

    PMID: 17637093BACKGROUND

  • Pryde 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.

    PMID: 12480096BACKGROUND

  • Rastall 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.

    PMID: 12459343BACKGROUND

  • Scott 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.

    PMID: 23147033BACKGROUND

  • Sokol H, Pigneur B, Watterlot L, Lakhdari O, Bermudez-Humaran LG, Gratadoux JJ, Blugeon S, Bridonneau C, Furet JP, Corthier G, Grangette C, Vasquez N, Pochart P, Trugnan G, Thomas G, Blottiere HM, Dore J, Marteau P, Seksik P, Langella P. Faecalibacterium prausnitzii is an anti-inflammatory commensal bacterium identified by gut microbiota analysis of Crohn disease patients. Proc Natl Acad Sci U S A. 2008 Oct 28;105(43):16731-6. doi: 10.1073/pnas.0804812105. Epub 2008 Oct 20.

    PMID: 18936492BACKGROUND

  • Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Dore J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807. doi: 10.1128/AEM.65.11.4799-4807.1999.

    PMID: 10543789BACKGROUND

  • Walker AW, Ince J, Duncan SH, Webster LM, Holtrop G, Ze X, Brown D, Stares MD, Scott P, Bergerat A, Louis P, McIntosh F, Johnstone AM, Lobley GE, Parkhill J, Flint HJ. Dominant and diet-responsive groups of bacteria within the human colonic microbiota. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.

    PMID: 20686513BACKGROUND

  • Zheng G, Yampara-Iquise H, Jones JE, Andrew Carson C. Development of Faecalibacterium 16S rRNA gene marker for identification of human faeces. J Appl Microbiol. 2009 Feb;106(2):634-41. doi: 10.1111/j.1365-2672.2008.04037.x.

    PMID: 19200327BACKGROUND

  • Chung WSF, Walker AW, Bosscher D, Garcia-Campayo V, Wagner J, Parkhill J, Duncan SH, Flint HJ. Relative abundance of the Prevotella genus within the human gut microbiota of elderly volunteers determines the inter-individual responses to dietary supplementation with wheat bran arabinoxylan-oligosaccharides. BMC Microbiol. 2020 Sep 14;20(1):283. doi: 10.1186/s12866-020-01968-4.

    PMID: 32928123DERIVED

MeSH Terms

Conditions

HypercholesterolemiaFlatulenceIntestinal Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Harry J Flint, Professor

    Rowett Institute of Nutrition and Health, University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 29, 2015

First Posted

February 29, 2016

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 2, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)