Effects of Fruit Consumption on Risk Factors of Chronic Disease

Vascular Stiffness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963416
• Other study ID #: UOR-0001
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: October 11, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Disease
• Vascular Stiffness

Intervention

Dietary Supplement:
• macro- and micro-nutrient matched control (240 ml)

• Orange juice

• whole orange fruit

• Processed whole orange

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	PepsiCo Global R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma flavanone metabolites		change from baseline to 6 hours	No
Primary	Flow mediated dilation		change in Flow Mediated Dilation response between baseline and 6 hours	No
Secondary	Postprandial plasma glucose		change in glucose from baseline to 2 hours	No
Secondary	Postprandial insulin		change from baseline to 2 hours	No
Secondary	global cognitive function		change from baseline to 6 hours	No
Secondary	Blood pressure		change from baseline to 6 hours	No
Secondary	postprandial non-esterified fatty acids		change from baseline to 6 hours	No
Secondary	Postprandial triacylglycerol		change from baseline to 6 hours	No
Secondary	total HDL/LDL		change from baseline to 6 hours	No
Secondary	Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)		change from baseline to 6 hours	No
Secondary	LDL oxidation		change from baseline to 6h	No