Effects of Fruit Consumption on Risk Factors of Chronic Disease

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.

Sponsors

Lead Sponsor: University of Reading

Collaborator: PepsiCo Global R&D

Source 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.

Overall Status Completed
Start Date June 2012
Completion Date December 2012
Primary Completion Date December 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Flow mediated dilation change in Flow Mediated Dilation response between baseline and 6 hours
Secondary Outcome
Measure Time Frame
Postprandial plasma glucose change in glucose from baseline to 2 hours
Postprandial insulin change from baseline to 2 hours
global cognitive function 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
Enrollment 34
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: macro- and micro-nutrient matched control (240 ml)

Arm Group Label: Control

Intervention Type: Dietary Supplement

Intervention Name: Orange juice

Arm Group Label: Orange juice

Intervention Type: Dietary Supplement

Intervention Name: whole orange fruit

Arm Group Label: whole orange

Intervention Type: Dietary Supplement

Intervention Name: Processed whole orange

Arm Group Label: processed whole orange

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).

Gender: Male

Minimum Age: 30 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: University of Reading
Location Countries

United Kingdom

Verification Date

October 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Reading

Investigator Full Name: Jeremy Paul Edward Spencer

Investigator Title: Professor of Nutritional Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Control

Type: Placebo Comparator

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

Label: Orange juice

Type: Experimental

Description: commercial orange juice (240 ml)

Label: whole orange

Type: Experimental

Description: whole orange fruit (240 ml)

Label: processed whole orange

Type: Experimental

Description: processed whole orange (240 ml)

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov