Vascular Stiffness
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTmacro- and micro-nutrient matched control (240 ml)
DIETARY_SUPPLEMENTOrange juice
DIETARY_SUPPLEMENTwhole orange fruit
DIETARY_SUPPLEMENTProcessed whole orange
Sponsors
PepsiCo Global R&D
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow mediated dilation | change in Flow Mediated Dilation response between baseline and 6 hours |
Secondary
| Measure | 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 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 |
| postprandial non-esterified fatty acids | change from baseline to 6 hours |
Other
| Measure | Time frame |
|---|---|
| Plasma flavanone metabolites | change from baseline to 6 hours |
Countries
United Kingdom
Outcome results
None listed