Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease

Study Overview
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Brief Summary
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Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors. The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population

Official Title
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Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population

Conditions
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Cardiovascular Disease, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: wholegrain cereals oats (WGO)
* Dietary Supplement: Non wholegrain cereals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women (age range 23-64 y) BMI of 18-30kg/m2 Fasting glucose concentration >5.5 but <7.5mmol/L Total cholesterol >5.2 but <7.8mmol/L Exclusion Criteria: medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis exposure to any investigational agent <42 d before the study presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption history of substance misuse or alcoholism current pregnancy, planned pregnancy, or given birth in the past 12 months antibiotic treatment 6 weeks previous to study start date allergy or intolerance to intervention breakfast cereals components smoking

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 64 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wholegrain cereal oats<br>Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period. | Dietary Supplement: wholegrain cereals oats (WGO)<br>* Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period<br>|
| Placebo Comparator: Non wholegrain cereals<br>Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period. | Dietary Supplement: Non wholegrain cereals<br>* Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in faecal bacteria population |  | Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal short chain fatty acids |  | High-performance liquid chromatography (HPLC) was performed to determine faecal SCFA concentration. Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days | 
| Changes in plasma lipids |  | Fasted plasma samples were analysed for determination of triacylglycerol (TAG), total cholesterol (TC), HDL-cholesterol, LDL-cholesterol. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days |