Processed Orange and the Glycemic Response

Completed · Not applicable

Conditions studied: Maximum Observed Plasma Glucose Concentration (Cmax)

In brief

Randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 3 intervention arms, consisting of a control (Product A), a low dose processed whole orange (Product B) and a high dose processed whole orange (Product C), to determine the effect of the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma insulin concentrations will be quantified.

Key facts

Study ID

NCT02112851

Run by

PepsiCo Global R&D

People needed

38

Starts

2014-03-07

Expected to finish

2016-01-01

Last updated by the study team

2021-03-10

Who can join

Age: 30 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males (due to potential hormonal fluctuations in female subjects) aged 30-65 y
• BMI: 25-29.9 kg/m2
• Not diabetic [diagnosed or fasting glucose >7 mmol/L (126 mg/dL)] or suffer from other endocrine disorders
• Not having suffered a myocardial infarction/stroke in the past 12 mo
• 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

You may not qualify if…

• Females
• Use of medications known to affect lipid metabolism, i.e., hypolipidemic or cholesterol-lowering agents (e.g., Pravastatin, Simuvustatin)
• Use of (>2x/wk) medication for inflammation or hypercoagulation
• Anticoagulants (Warfarin)
• Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids (Betamethasone)
• Regular use (>2x/wk) of any acid-lowering medications, laxatives or anti-diarrheal medications (prescription or over-the-counter [OTC])
• Use of medications known or suspected to influence blood pressure, including beta-adrenergic blocking agents (oral or ocular) (e.g., Sotalol, Bisoprolol), beta-adrenergic drugs, calcium channel blocking agents (Amlodipine, Nicardipine), angiotensin converting enzyme (ACE) inhibitors (Captopril, Cilazapril), angiotensin receptor blocking agents (Valsartan), nitrates, diuretics (Chlortalidone), venlafaxine and sibutramine, decongestants or chloroquine
• Systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg
• CVD including coronary artery disease, left ventricular hypertrophy, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease or dysautonomia
• Gastrointestinal diseases conditions or medications influencing gastrointestinal absorption including active peptic ulcer disease, treatment with acid-lowering drugs or inflammatory bowel disease
• Renal or chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis or serum creatinine >1.5 mg/dL
• Endocrine disorders including diabetes [fasting blood glucose >7 mmol/L (126 mg/dL) or current pharmacologic treatment for diabetes], untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease or hyperuricemia
• Rheumatologic diseases including gout or inflammatory arthritis
• Active treatment for cancer of any type (except basal cell carcinoma)<1 y
• Regular use of oral steroids except topical OTC steroids
• Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies. However, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 3) may be considered eligible.
• Usual daily ethanol intake of>2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
• Cigarette smoking and/or nicotine replacement use. However, subjects who have stopped using these products for 1 y prior to their initial visit (Visit 1) may be considered eligible.
• Illicit drug use
• Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
• Specific laboratory blood or urine analysis parameters of:
• Creatinine > 1.5 mg/dL
• Electrolytes, calcium, phosphorous - out of normal ranges
• ALT and AST >1.5 nmol
• Total bilirubin - above normal range

Where it is running

• Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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