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| Name | Class |
|---|---|
| PepsiCo Global R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | macro- and micro-nutrient matched control (240 ml) |
|
| Orange juice | Experimental | commercial orange juice (240 ml) |
|
| whole orange | Experimental | whole orange fruit (240 ml) |
|
| processed whole orange | Experimental | processed whole orange (240 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| macro- and micro-nutrient matched control (240 ml) | Dietary Supplement |
| ||
| Orange juice |
| Measure | Description | Time Frame |
|---|---|---|
| Flow mediated dilation | change in Flow Mediated Dilation response between baseline and 6 hours |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma flavanone metabolites | change from baseline to 6 hours |
Inclusion Criteria:
Exclusion Criteria:
Females
Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Reading | Berkshire | RG2 9AR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27170728 | Derived | Dong H, Rendeiro C, Kristek A, Sargent LJ, Saunders C, Harkness L, Rowland I, Jackson KG, Spencer JP, Lovegrove JA. Addition of Orange Pomace to Orange Juice Attenuates the Increases in Peak Glucose and Insulin Concentrations after Sequential Meal Ingestion in Men with Elevated Cardiometabolic Risk. J Nutr. 2016 Jun;146(6):1197-203. doi: 10.3945/jn.115.226001. Epub 2016 May 11. |
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| Dietary Supplement |
|
| whole orange fruit | Dietary Supplement |
|
| Processed whole orange | Dietary Supplement |
|
| 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 |