Processed Orange and the Glycemic Response

NCT ID: NCT02112851

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-07
• Study Completion Date: 2016-01-31

Brief Summary

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.

Detailed 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.

Conditions

Maximum Observed Plasma Glucose Concentration (Cmax)

Study Design

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

Study Groups

Orange flavored beverage

240ml orange beverage

Group Type: PLACEBO_COMPARATOR

Orange flavored beverage

Intervention Type: OTHER

Intervention involves consumption of one beverage of 240ml following baseline measurements

Orange flavored beverage - Test1

240ml processed whole orange low dose

Group Type: EXPERIMENTAL

Orange flavored beverage

Intervention Type: OTHER

Intervention involves consumption of one beverage of 240ml following baseline measurements

Orange flavored beverage - Test2

240ml processed whole orange high dose

Group Type: EXPERIMENTAL

Orange flavored beverage

Intervention Type: OTHER

Intervention involves consumption of one beverage of 240ml following baseline measurements

Interventions

Orange flavored beverage

Intervention involves consumption of one beverage of 240ml following baseline measurements

Intervention Type: OTHER

Eligibility Criteria

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.

• 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: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tufts University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

PEP-1326

Identifier Type: -

Identifier Source: org_study_id