Effects of Fruit Consumption on Risk Factors of Chronic Disease

Not Applicable

Completed

• Conditions: Vascular Stiffness
• Interventions: Dietary Supplement: whole orange fruit; Dietary Supplement: Orange juice; Dietary Supplement: macro- and micro-nutrient matched control (240 ml); Dietary Supplement: Processed whole orange

• Registration Number: NCT01963416
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Last Update Submitted: 2013-10-11
• Study First Posted: 2013-10-16
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
whole orange	whole orange fruit	whole orange fruit (240 ml)
Orange juice	Orange juice	commercial orange juice (240 ml)
Control	macro- and micro-nutrient matched control (240 ml)	macro- and micro-nutrient matched control (240 ml)
processed whole orange	Processed whole orange	processed whole orange (240 ml)

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation	change in Flow Mediated Dilation response between baseline and 6 hours

Secondary Outcome Measures

Name	Time	Method
Postprandial triacylglycerol	change from baseline to 6 hours
total HDL/LDL	change from baseline to 6 hours
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
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

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom