Effects of Fruit Consumption on Risk Factors of Chronic Disease

NCT ID: NCT01963416

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Vascular Stiffness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

Orange juice

commercial orange juice (240 ml)

Group Type: EXPERIMENTAL

Orange juice

Intervention Type: DIETARY_SUPPLEMENT

whole orange

whole orange fruit (240 ml)

Group Type: EXPERIMENTAL

whole orange fruit

Intervention Type: DIETARY_SUPPLEMENT

processed whole orange

processed whole orange (240 ml)

Group Type: EXPERIMENTAL

Processed whole orange

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Orange juice

Intervention Type: DIETARY_SUPPLEMENT

whole orange fruit

Intervention Type: DIETARY_SUPPLEMENT

Processed whole orange

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Paul Edward Spencer

Professor of Nutritional Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Reading

Reading, Berkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27170728 (View on PubMed)

Other Identifiers

UOR-0001

Identifier Type: -

Identifier Source: org_study_id