Bioactive Phytochemicals From Wheat Bran

Study Overview
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Brief Summary
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There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It is still not clear exactly why this happens, but it is likely that the compounds which enter our bodies when we eat such products are responsible. In this study we plan to find out what these compounds are and where they are found. The investigators will do this by asking volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood, urine and stool samples over the next twenty-four hours. Once the investigators know how much and which compounds are present, we can then find out possible reasons why they are protective, for example by looking to see whether they are anti-inflammatory. We also plan to look at whether if having a diet which contains either a lot of wheat-bran products or very low amounts of these foods effects how they are absorbed by the body. HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are metabolized to compounds responsible for high cellular bioactivity imparting important health benefits.

Official Title
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Identification of Novel Bioactive Compounds in Wheat Bran

Conditions
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Bio-availability of Wheat Bran Phytochemicals in the Human Gut, Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation

Intervention / Treatment
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* Other: Visit A high wheat bran
* Other: Visit B normal wheat bran
* Other: Follow up normal (8days) and high (1day) bran consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers will be healthy males or females and aged between 18 and 55 years who have a documented low (less than 1 portion per week) or high (more than or equal 5 portions per week) consumption of wheat bran and are able to give informed consent. Exclusion Criteria: are taking any medicines prescribed by their general practitioner are taking drugs to lower high cholesterol levels or high blood pressure regularly take analgesics, antipyretic or anti-inflammatories regularly take nutritional supplements have taken antibiotics in the last three months have given a large blood donation in last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Visit A- 120g wheat bran cereals<br>A morning vist where volunteers consumed 120g of wheat bran cereals with 125ml semi-skimmed milk | Other: Visit A high wheat bran<br> <br> |
| Other: Visit B-40g wheat bran cereals<br>A morning vist where volunteers consumed 40g of wheat bran cereals with 375 ml semi-skimmed milk | Other: Visit B normal wheat bran<br> <br> |
| Other: Follow up-40g (8days), 120g (1day) wheat bran cereals<br>Volunteers follow their normal diet but they were asked to consume 40g wheat bran cereals with 125 ml semi-skimmed milk for eight days and on day nine 120g wheat bran cereals with 375ml semi-skimmed milk | Other: Follow up normal (8days) and high (1day) bran consumption<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human bioavailability of benzoic acids and derivatives from wheat bran cereals | The analysis of the benzoic acid and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24 h | 
| Human bioavailability of cinnamic acids and derivatives from wheat bran cereals | The analysis of the cinnamic acids and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | 
| Human bioavailability of phenylpropanoid dimers from wheat bran cereals | The analysis of the phenylpropanoid dimers metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | 
| Human bioavailability of phenyl propionic acids from wheat bran cereals | The analysis of the phenyl propionic acids metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | 
| Bioavailability of benzaldehydes from wheat bran | The analysis of the benzaldehydes metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | 
| Human bioavailability of acetophenones from wheat bran cereals | The analysis of the acetophenones metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | 
| Human bioavailability of lignans from wheat bran cereals | The analysis of the lignans metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24 h | 
| Short chain fatty acids profile after wheat bran consumption (acute) | Short chain fatty acids profile in faecal samples at 0h (baseline) and 24h after wheat bran consumption (40g and 120g). | 24 h | 
| Short chain fatty acids profile after wheat bran consumption (chronic) | Short chain fatty acids profile in in faecal samples at day 0 (baseline), day 5 (during 7 days consumption of 40g wheat bran cereals/day) and day 10 (after 120g wheat bran cereals consumption on day 9). | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheat bran cereals, bran phytochemicals, phytochemicals bioavailability