Effects of Fruit Consumption on Risk Factors of Chronic Disease

University of Reading

Status: Completed

Conditions: Vascular Stiffness

Treatments: Dietary Supplement: Orange juice; Dietary Supplement: whole orange fruit; Dietary Supplement: macro- and micro-nutrient matched control (240 ml); Dietary Supplement: Processed whole orange

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01963416

UOR-0001

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

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

Orange juice

Experimental group

Description:

commercial orange juice (240 ml)

Treatment:

Dietary Supplement: Orange juice

whole orange

Experimental group

Description:

whole orange fruit (240 ml)

Treatment:

Dietary Supplement: whole orange fruit

processed whole orange

Experimental group

Description:

processed whole orange (240 ml)

Treatment:

Dietary Supplement: Processed whole orange