Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Flatulence Intestinal Diseases Dietary Supplement: Placebo Dietary Supplement: Fibre supplement Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Placebo Comparator: Placebo
15 g/day maltodextrin in 3 portions of 5 g.
Dietary Supplement: Placebo
15 g/day maltodextrin in 3 portions of 5 g.

Active Comparator: Fibre supplement
15 g/day Wheat Bran Extract in 3 portions of 5 g.
Dietary Supplement: Fibre supplement
15 g/day Wheat Bran Extract in 3 portions of 5 g.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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/

  9. 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.

  10. 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 from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693782


Locations
Layout table for location information
United Kingdom
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, United Kingdom, AB21 9SB
Sponsors and Collaborators
University of Aberdeen
Cargill
Investigators
Layout table for investigator information
Principal Investigator: Harry J Flint, Professor Rowett Institute of Nutrition and Health, University of Aberdeen

Publications:

Layout table for additonal information
Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02693782     History of Changes
Other Study ID Numbers: 15/HSMC/004
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Aberdeen:
Fibre
Wheat Bran Extract
Microbiota
Microbiota metabolites
Gastrointestinal tolerance
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Hypercholesterolemia
Flatulence
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms