Clinical trial NCT01963416: Effects of Fruit Consumption on Risk Factors of Chronic Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Stiffness
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
First posted: 2013-10-16
Enrollment: 34
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Flow mediated dilation
timeFrame: change in Flow Mediated Dilation response between baseline and 6 hours
Secondary outcomes:
measure: Postprandial plasma glucose
timeFrame: change in glucose from baseline to 2 hours
measure: Postprandial insulin
timeFrame: change from baseline to 2 hours
measure: global cognitive function
timeFrame: change from baseline to 6 hours
measure: Blood pressure
timeFrame: change from baseline to 6 hours
measure: postprandial non-esterified fatty acids
timeFrame: change from baseline to 6 hours
measure: Postprandial triacylglycerol
timeFrame: change from baseline to 6 hours
measure: total HDL/LDL
timeFrame: change from baseline to 6 hours
measure: Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)
timeFrame: change from baseline to 6 hours
measure: LDL oxidation
timeFrame: change from baseline to 6h
Other outcomes:
measure: Plasma flavanone metabolites
timeFrame: change from baseline to 6 hours
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
citation: 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.