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

Study Overview
=================
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.

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

Conditions
-----------------
Hypercholesterolemia, Flatulence, Intestinal Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Fibre supplement


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>15 g/day maltodextrin in 3 portions of 5 g. | Dietary Supplement: Placebo<br>* 15 g/day maltodextrin in 3 portions of 5 g.<br>|
| Active Comparator: Fibre supplement<br>15 g/day Wheat Bran Extract in 3 portions of 5 g. | Dietary Supplement: Fibre supplement<br>* 15 g/day Wheat Bran Extract in 3 portions of 5 g.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the gut microbiota | Sample will be used for microbiota analysis using molecular methods such as high-throughput sequencing and qPCR. | 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. | 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. | 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. | 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. | 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. | 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 | 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/ | 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. | day 35 | 
| Changes in faecal inflammatory markers | Faecal calprotectin will be measured using ELISA method. | Faecal samples collected on each test day (day 5, 10, 15, 20, 25, 30, 35) over an expected period of 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibre, Wheat Bran Extract, Microbiota, Microbiota metabolites, Gastrointestinal tolerance