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Effects of Fruit Consumption on Risk Factors of Chronic Disease

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ClinicalTrials.gov Identifier: NCT01963416
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Sponsor:
Collaborator:
PepsiCo Global R&D
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

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.

Condition or disease Intervention/treatment Phase
Vascular Stiffness Dietary Supplement: macro- and micro-nutrient matched control (240 ml) Dietary Supplement: Orange juice Dietary Supplement: whole orange fruit Dietary Supplement: Processed whole orange Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
macro- and micro-nutrient matched control (240 ml)
Dietary Supplement: macro- and micro-nutrient matched control (240 ml)
Experimental: Orange juice
commercial orange juice (240 ml)
Dietary Supplement: Orange juice
Experimental: whole orange
whole orange fruit (240 ml)
Dietary Supplement: whole orange fruit
Experimental: processed whole orange
processed whole orange (240 ml)
Dietary Supplement: Processed whole orange



Primary Outcome Measures :
  1. Flow mediated dilation [ Time Frame: change in Flow Mediated Dilation response between baseline and 6 hours ]

Secondary Outcome Measures :
  1. Postprandial plasma glucose [ Time Frame: change in glucose from baseline to 2 hours ]
  2. Postprandial insulin [ Time Frame: change from baseline to 2 hours ]
  3. global cognitive function [ Time Frame: change from baseline to 6 hours ]
  4. Blood pressure [ Time Frame: change from baseline to 6 hours ]
  5. postprandial non-esterified fatty acids [ Time Frame: change from baseline to 6 hours ]
  6. Postprandial triacylglycerol [ Time Frame: change from baseline to 6 hours ]
  7. total HDL/LDL [ Time Frame: change from baseline to 6 hours ]
  8. Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP) [ Time Frame: change from baseline to 6 hours ]
  9. LDL oxidation [ Time Frame: change from baseline to 6h ]

Other Outcome Measures:
  1. Plasma flavanone metabolites [ Time Frame: change from baseline to 6 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963416


Locations
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United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG2 9AR
Sponsors and Collaborators
University of Reading
PepsiCo Global R&D

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeremy Paul Edward Spencer, Professor of Nutritional Medicine, University of Reading
ClinicalTrials.gov Identifier: NCT01963416     History of Changes
Other Study ID Numbers: UOR-0001
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes
Trace Elements
Nutrients
Micronutrients
Growth Substances
Physiological Effects of Drugs