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Completed

NCT Number: NCT01963416

Effects of Fruit Consumption on Risk Factors of Chronic Disease

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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Key information

Conditions

Vascular Stiffness

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG2 9AR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

macro- and micro-nutrient matched control (240 ml)

Dietary Supplement

Orange Juice

Dietary Supplement

whole orange fruit

Dietary Supplement

Processed whole orange

Dietary Supplement

Primary outcomes

  1. Flow mediated dilation

    Time frame: change in Flow Mediated Dilation response between baseline and 6 hours

Secondary outcomes

  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 outcomes

  1. Plasma flavanone metabolites

    Time frame: change from baseline to 6 hours

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • PepsiCo Global R&D

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2013
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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