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Trial record 16 of 82 for:    extract | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT02693782
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Cargill
Information provided by (Responsible Party):
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE June 29, 2015
First Posted Date  ICMJE February 29, 2016
Last Update Posted Date May 2, 2017
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02693782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • 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 Measures  ICMJE
 (submitted: February 23, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fabulous Fibre Study - Effect of Wheat Bran Extract on Gut and General Health in Healthy Aging Subjects (FFS)
Official Title  ICMJE 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
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hypercholesterolemia
  • Flatulence
  • Intestinal Diseases
Intervention  ICMJE
  • Dietary Supplement: Placebo
    15 g/day maltodextrin in 3 portions of 5 g.
  • Dietary Supplement: Fibre supplement
    15 g/day Wheat Bran Extract in 3 portions of 5 g.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    15 g/day maltodextrin in 3 portions of 5 g.
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Fibre supplement
    15 g/day Wheat Bran Extract in 3 portions of 5 g.
    Intervention: Dietary Supplement: Fibre supplement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
30
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693782
Other Study ID Numbers  ICMJE 15/HSMC/004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Cargill
Investigators  ICMJE
Principal Investigator: Harry J Flint, Professor Rowett Institute of Nutrition and Health, University of Aberdeen
PRS Account University of Aberdeen
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP