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Effects of Fruit Consumption on Risk Factors of Chronic Disease

Primary Purpose

Vascular Stiffness

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
macro- and micro-nutrient matched control (240 ml)
Orange juice
whole orange fruit
Processed whole orange
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vascular Stiffness

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Reading

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control

Orange juice

whole orange

processed whole orange

Arm Description

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

commercial orange juice (240 ml)

whole orange fruit (240 ml)

processed whole orange (240 ml)

Outcomes

Primary Outcome Measures

Flow mediated dilation

Secondary Outcome Measures

Postprandial plasma glucose
Postprandial insulin
global cognitive function
Blood pressure
postprandial non-esterified fatty acids
Postprandial triacylglycerol
total HDL/LDL
Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)
LDL oxidation

Full Information

First Posted
October 10, 2013
Last Updated
October 11, 2013
Sponsor
University of Reading
Collaborators
PepsiCo Global R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01963416
Brief Title
Effects of Fruit Consumption on Risk Factors of Chronic Disease
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
PepsiCo Global R&D

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Stiffness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
macro- and micro-nutrient matched control (240 ml)
Arm Title
Orange juice
Arm Type
Experimental
Arm Description
commercial orange juice (240 ml)
Arm Title
whole orange
Arm Type
Experimental
Arm Description
whole orange fruit (240 ml)
Arm Title
processed whole orange
Arm Type
Experimental
Arm Description
processed whole orange (240 ml)
Intervention Type
Dietary Supplement
Intervention Name(s)
macro- and micro-nutrient matched control (240 ml)
Intervention Type
Dietary Supplement
Intervention Name(s)
Orange juice
Intervention Type
Dietary Supplement
Intervention Name(s)
whole orange fruit
Intervention Type
Dietary Supplement
Intervention Name(s)
Processed whole orange
Primary Outcome Measure Information:
Title
Flow mediated dilation
Time Frame
change in Flow Mediated Dilation response between baseline and 6 hours
Secondary Outcome Measure Information:
Title
Postprandial plasma glucose
Time Frame
change in glucose from baseline to 2 hours
Title
Postprandial insulin
Time Frame
change from baseline to 2 hours
Title
global cognitive function
Time Frame
change from baseline to 6 hours
Title
Blood pressure
Time Frame
change from baseline to 6 hours
Title
postprandial non-esterified fatty acids
Time Frame
change from baseline to 6 hours
Title
Postprandial triacylglycerol
Time Frame
change from baseline to 6 hours
Title
total HDL/LDL
Time Frame
change from baseline to 6 hours
Title
Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)
Time Frame
change from baseline to 6 hours
Title
LDL oxidation
Time Frame
change from baseline to 6h
Other Pre-specified Outcome Measures:
Title
Plasma flavanone metabolites
Time Frame
change from baseline to 6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 9AR
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27170728
Citation
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.
Results Reference
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Effects of Fruit Consumption on Risk Factors of Chronic Disease

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