Effects of Fruit Consumption on Risk Factors of Chronic Disease

Study Overview
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Brief Summary
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Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.

Official Title
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A Randomized Controlled, Crossover in Design, Double Blind Clinical Trial Investigating the Effects of Whole Versus Processed Fruit Consumption on Risk Factors for Chronic Disease and Performance Indicators.

Conditions
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Vascular Stiffness

Intervention / Treatment
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* Dietary Supplement: macro- and micro-nutrient matched control (240 ml)
* Dietary Supplement: Orange juice
* Dietary Supplement: whole orange fruit
* Dietary Supplement: Processed whole orange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males due to potential hormonal fluctuations in female subjects Aged 30-65years Fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol >0.8 mmol/l or a BMI 25-32 kg/m2. Not having suffered a myocardial infarction/stroke in the past 12 months Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation No history of alcohol misuse Not planning or on a weight reducing regime Not taking any fish oil, fatty acid or vitamin and mineral supplements Non smokers Not suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11). Not suffering from mild cognitive impairment or dementia according to the MMSE (score ≥ 25). Exclusion Criteria: Females Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation Hypertension - ACE Inhibitors (e.g. Captopril, Cilazapril), Angiotensin Receptor Blockers (Valsartan), Calcium Channel Blockers (Amlodipine, Nicardipine), Diuretics (Chlortalidone) or Beta blockers (Sotalol, Bisoprolol). Cholesterol lowering (Pravastatin, Simuvustatin) Anticoagulants (Warfarin) Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids(Betamethasone) Strict vegetarians Smokers Those on or planning a weight reducing regime Blood glucose, haemaglobin or liver enzymes outside of the normal range Unable to consume study meals Those suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11). Those suffering from mild cognitive impairment or dementia as indicated by the MMSE (score < 25).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>macro- and micro-nutrient matched control (240 ml) | Dietary Supplement: macro- and micro-nutrient matched control (240 ml)<br> <br> |
| Experimental: Orange juice<br>commercial orange juice (240 ml) | Dietary Supplement: Orange juice<br> <br> |
| Experimental: whole orange<br>whole orange fruit (240 ml) | Dietary Supplement: whole orange fruit<br> <br> |
| Experimental: processed whole orange<br>processed whole orange (240 ml) | Dietary Supplement: Processed whole orange<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilation |  | change in Flow Mediated Dilation response between baseline and 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma glucose |  | change in glucose from baseline to 2 hours | 
| Postprandial insulin |  | change from baseline to 2 hours | 
| global cognitive function |  | change from baseline to 6 hours | 
| Blood pressure |  | change from baseline to 6 hours | 
| postprandial non-esterified fatty acids |  | change from baseline to 6 hours | 
| Postprandial triacylglycerol |  | change from baseline to 6 hours | 
| total HDL/LDL |  | change from baseline to 6 hours | 
| Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP) |  | change from baseline to 6 hours | 
| LDL oxidation |  | change from baseline to 6h |