Processed Orange and the Glycemic Response (POGR)

PepsiCo

Status: Completed

Conditions: Maximum Observed Plasma Glucose Concentration (Cmax)

Treatments: Other: Orange flavored beverage

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112851

PEP-1326

Details and patient eligibility

About

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.

Full description

The study design is a randomized, placebo controlled, double-blind, crossover. This trial will include 33 subjects randomized to receive products A, B or C [240 mL (255 g)]. Subjects will be randomly assigned to one of 6 sequences of 3 interventions. After the initial screening visit, subjects will visit the Clinical and Translational Research Center (CTRC) the Tufts Translational and Clinical Science Institute (CTSI) on three separate occasions. Following each intervention day there will be a two week wash out period.

Enrollment: 38 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 30-65 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

Exclusion criteria

• 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
  • Triglycerides ≥300 mg/dL
  • Fasting glucose ≥126 mg/dL
  • CBC: HCT outside of normal NEL reference ranges at the discretion of the study physician
  • WBC, PLT - outside of normal NEL reference ranges Strict vegetarians

• Those on or planning a weight reducing regime

• Unable to consume study meals or products

• Subjects with larger than 5 kg weight loss in the last 3 months.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 3 patient groups, including a placebo group

Orange flavored beverage

Placebo Comparator group

Description:

240ml orange beverage

Treatment:

Other: Orange flavored beverage

Orange flavored beverage - Test1

Experimental group

Description:

240ml processed whole orange low dose

Treatment:

Other: Orange flavored beverage

Orange flavored beverage - Test2

Experimental group

Description:

240ml processed whole orange high dose

Treatment:

Other: Orange flavored beverage