Clinical Trial: Fabulous Fibre Study - Effect of Wheat Bran Extract on Gut and General Health in Healthy Aging Subjects (FFS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Mai

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).


Detailed Summary:

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 bl
Sponsor: University of Aberdeen

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Sample will be used for microbiota analysis using molecular methods such as high-throughput sequencing and qPCR.
  • 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 ]
    Blood samples will be measured for glucose using the Cholestech method.
  • 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 ]
    Blood samples will be measured for HDL using the Cholestech method.
  • 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 ]
    Blood samples will be measured for LDL using the Cholestech method.
  • 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 ]
    Blood samples will be measured for triglycerides using the Cholestech method.
  • 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 ]
    Blood samples will be measured for cholesterol using the Cholestech method.
  • Gastrointestinal tolerance [ Time Frame: This is assessed via a daily questionnaire throughout the whole study period of 35 days. ]

    A daily questionnaire will be asked on:

    • Nausea
    • Bloating
    • Flatulence
    • Cramps
    • Bowel movements
    • Stool appearance
  • 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) ]
    A Food Frequency Questionnaire (FFQ) will be completed at the start and the end of the study. http://www.foodfrequency.org/
  • General health and well-being (This is assessed via questionnaires at the end of the study) [ Time Frame: day 35 ]
    A health survey will be completed at the end of the study on activities, physical and emotional well-being.
  • 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 ]
    Faecal calprotectin will be measured using ELISA method.


Original Secondary Outcome:

  • 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 ]
    Sample will be used for microbiota analysis using molecular methods such as high-throughput sequencing and qPCR.
  • 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 ]
    Blood samples will be measured for glucose using the Cholestech method.
  • 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 ]
    Blood samples will be measured for HDL using the Cholestech method.
  • 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 ]
    Blood samples will be measured for LDL using the Cholestech method.
  • 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 ]
    Blood samples will be measured for triglycerides using the Cholestech method.
  • 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 ]
    Blood samples will be measured for cholesterol using the Cholestech method.
  • Gastrointestinal tolerance [ Time Frame: This is assessed via a daily questionnaire throughout the whole study period of 35 days. ]

    A daily questionnaire will be asked on:

    • Nausea
    • Bloating
    • Flatulence
    • Cramps
    • Bowel movements
    • Stool appearance
  • 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) ]
    A Food Frequency Questionnaire (FFQ) will be completed at the start and the end of the study. http://www.foodfrequency.org/
  • General health and well-being [ Time Frame: This is assessed via questionnaires at the end of the study (day 35) ]
    A health survey will be completed at the end of the study on activities, physical and emotional well-being.
  • 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 ]
    Faecal calprotectin will be measured using ELISA method.


Information By: University of Aberdeen

Dates:
Date Received: June 29, 2015
Date Started: June 2015
Date Completion:
Last Updated: May 1, 2017
Last Verified: September 2016