Effects of Fruit Consumption on Risk Factors of Chronic Disease

October 11, 2013 updated by: Jeremy Paul Edward Spencer, University of Reading

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 9AR
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Plasma flavanone metabolites
Time Frame: change from baseline to 6 hours
change from baseline to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

PepsiCo Global R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOR-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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